Supplementation In People Research Articles

Feasibility of a randomised controlled trial of fish oil supplementation in people with chronic obstructive pulmonary disease

Feasibility of a randomised controlled trial of fish oil supplementation in people with chronic obstructive pulmonary disease

Review of randomized controlled trials of nutritional supplementation in people living with HIV

Review of randomized controlled trials of nutritional supplementation in people living with HIV Alicia Sneij, Adriana Campa, Marianna K Baum Stempel College of Public Health and Social Work, Florida International University, Modesto Maidique Campus, Miami, FL, USA Background: Nutritional deficiencies are widespread in people living with HIV (PLWH), prior to the antiretroviral treatment (ART). Nutrient deficiencies and other nutrition-related conditions, however, have been identified in patients receiving ART. Trials of nutritional supplementation have been conducted to alleviate these nutritional conditions and improve or reverse nutrition-related outcomes. This review aims to evaluate the benefits of supplementation, its unintended adverse effects, and the difference in approach and focus, research design, formulations, and outcomes between those randomized clinical trials (RCTs) conducted before and after the initiation of ART. Methods: An evidence-based systematic review of the literature was conducted using electronic databases and the resources of the Florida International University Research Library. Forty-two RCTs were selected for review, and their design and outcomes were compared and contrasted conceptually and in the form of tables. Results: Most of the RCTs (n=31) were conducted before the advent of ART, and their aims were delaying disease progression, reversing malnutrition, and improving pregnancy outcomes in women and infants infected with HIV. The RCTs conducted with coadministration of ART were fewer (n=11), with relative smaller sample size, of shorter duration, and mainly focused on preventing or ameliorating the nutrition-related conditions generated by the chronic infection, its treatment, and the aging of PLWH. Conclusion: As ART is becoming more accessible worldwide, and people are living longer with the disease, more longitudinal trials of nutritional interventions with larger sample sizes are needed to study the nutritional consequences and potential treatments for PLWH. Keywords: HIV, antiretroviral therapy, micronutrients, probiotics, AIDS, randomization, clinical trial

Folate supplementation in people with sickle cell disease.

Folate supplementation in people with sickle cell disease.

Omega-3 fatty acids for cystic fibrosis

Studies suggest that a diet rich in omega-3 essential fatty acids may have beneficial anti-inflammatory effects for chronic conditions such as cystic fibrosis. This is an updated version of a previously published review. To determine whether there is evidence that omega-3 polyunsaturated fatty acid supplementation reduces morbidity and mortality and to identify any adverse events associated with supplementation. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Authors and persons interested in the subject of the review were contacted.Date of last search: 13 August 2013. Randomised controlled trials in people with cystic fibrosis comparing omega-3 fatty acid supplements with placebo. Two authors independently selected studies for inclusion, extracted data and assessed the risk of bias of the studies. The searches identified 15 studies; four studies with 91 participants (children and adults) were included; duration of studies ranged from six weeks to six months. Two studies were judged to be at low risk of bias based on adequate randomisation but this was unclear in the other two studies. Three of the studies adequately blinded patients, however, the risk of bias was unclear in all studies with regards to allocation concealment and selective reporting.Two studies compared omega-3 fatty acids to olive oil for six weeks. One study compared a liquid dietary supplement containing omega-3 fatty acids to one without for six months. One study compared omega-3 fatty acids and omega-6 fatty acids to a control (capsules with customised fatty acid blends) for three months. Only one short-term study (19 participants) comparing omega-3 to placebo reported a significant improvement in lung function and Shwachman score and a reduction in sputum volume in the omega-3 group. Another study (43 participants) demonstrated a significant increase in serum phospholipid essential fatty acid content and a significant drop in the n-6/n-3 fatty acid ratio following omega-3 fatty acid supplementation compared to control. The longer-term study (17 participants) demonstrated a significant increase in essential fatty acid content in neutrophil membranes and a significant decrease in the leukotriene B4 to leukotriene B5 ratio in participants taking omega-3 supplements compared to placebo. This review found that regular omega-3 supplements may provide some benefits for people with cystic fibrosis with relatively few adverse effects, although evidence is insufficient to draw firm conclusions or recommend routine use of these supplements in people with cystic fibrosis. This review has highlighted the lack of data for many outcomes meaningful to people with or making treatment decisions about cystic fibrosis. A large, long-term, multicentre, randomised controlled study is needed to determine any significant therapeutic effect and to assess the influence of disease severity, dosage and duration of treatment. Future researchers should note the need for additional pancreatic enzymes.

ANTIOXIDANT SUPPLEMENTS IN ALZHEIMER’S DEMENTIA AND MILD COGNITIVE IMPAIRMENT: A SYSTEMATIC REVIEW

Objective: Current treatments have only a modest effect on impairment in Alzheimer’s Dementia (AD) and there is no treatment currently licensed for Mild Cognitive Impairment (MCI). Oxidative stress is postulated to play a role in the pathogenesis of AD and MCI and this provides a rationale for treatment with antioxidant supplements. The aim of this review is to evaluate the effect of antioxidant supplements in people with AD and MCI. Methods: A systematic review of published randomised controlled trials was carried out. 4 electronic databases were searched. Studies were included if they compared the use of a placebo with the following antioxidant supplements in people with AD or MCI: Vitamin e, vitamin c, selenium, alpha lipoic acid, phenols, zinc, curcumin, beta carotene, coenzyme Q10, melatonin. The primary outcome measure was cognitive impairment. Secondary outcome measures included functional impairment, behavioural disturbance and safety. Results: 10 trials were identified which met the inclusion criteria. Outcome data was not suitable for meta-analysis. 5 studies reported a small positive treatment effect on cognition and 1 reported a negative effect. 2 reported a positive treatment effect on functional ability and 1 on behaviour. There were no consistent adverse effects found overall however two studies raised concern of possible worsening of cognition in certain circumstances. Conclusions: The findings of this systematic review do not support the use of antioxidant supplements to slow cognitive, functional or behavioural deterioration in people with AD or MCI. However the majority of included studies had a high or unknown risk of bias. In the one study which had a low overall risk of bias, there was evidence that antioxidant supplements may have a positive effect on functional decline in AD. The overall risk of harm associated with short term antioxidant supplementation appears to be low however caution is warranted. Further studies evaluating the role of oxidative stress in the pathogenesis of AD are suggested.

In vitro evidence for efficacy in food intolerance for the multispecies probiotic formulation Ecologic® Tolerance (Syngut™).

The beneficial effects of probiotics are currently the subject of extensive studies in health and medical research. The aim of this research was to specifically design a new probiotic formulation for supplementation in people suffering from food intolerance. The selection of strains was focussed on the capacity to influence mechanisms of action that are important in development of food intolerance with the following parameters measure: in vitro capacity to produce β-galactosidase, in vitro strengthening of the epithelial barrier, in vitro stimulation of cytokines produced by regulatory T cells, in addition to assessing fundamental quality criteria (stability, gastrointestinal (GI)-survival, multispecies concept, allergen-free). Ecologic®Tolerance/Syngut™ was subsequently developed consisting of a multispecies concept using 4 different probiotic strains (Bifidobacterium lactis W51, Lactobacillus acidophilus W22, Lactobacillus plantarum W21 and Lactococcus lactis W19). Each of these strains demonstrated ability to survive the GI-tract and strain specific effects in producing β-galactosidase, strengthening the gut barrier function after immunological-induced stress and inhibiting Th2 cytokines (IL-4, IL-5 and IL-13 (≥50%), in addition to stimulating interleukin-10 levels; thus, providing in vitro evidence for the efficacy of the selected strains to provide beneficial effects in patients suffering from food intolerance.

Study of vitamin D supplementation in people over 65 years in primary care

Most of the elderly have vitamin D deficiency, which is defined as a serum level below 30 ng/mL. To identify the characteristics of patients over 65 receiving vitamin D supplements by their primary care physician. A descriptive and transverse study was performed on patients over 65 years old admitted to Care Following at the La Croix Rouge in Nantes from September 2012 to February 2013. The criteria for vitamin D supplementation, the type (vitamin D2 or D3, continuous prescription or not, route of administration) and starting date of vitamin D supplementation were identified. Serum 25-hydroxyvitamin D (25OHD) was measured at admission. Of 163 patients included, 44% received vitamin D supplements (n=71). The patient aged over 80 benefited more often from vitamin D supplementation (p=0.019), so did women (p=0.034), patients with fractures (p=0.05), patients with osteoporosis treatments (p<0.001) and those treated with long-term corticosteroids (p<0.001). Dark skinned patients received vitamin D supplementation less often than the others (p=0.046). The dosage of the vitamin D was normal for 28% of patients (n=46). The prescription of vitamin D supplements to the elderly is still too scarce and should be encouraged, especially in non-bone indications.

Omega 3 fatty acids for preventing or slowing the progression of age-related macular degeneration.

Evidence from animal models and observational studies in humans has suggested that there is an inverse relationship between dietary intake of omega 3 long-chain polyunsaturated fatty acids (LCPUFA) and risk of developing age-related macular degeneration (AMD) or progression to advanced AMD. To review the evidence that increasing the levels of omega 3 LCPUFA in the diet (either by eating more foods rich in omega 3 or by taking nutritional supplements) prevents AMD or slows the progression of AMD. We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015, Issue 1), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to February 2015), EMBASE (January 1980 to February 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to February 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 2 February 2015. We included randomised controlled trials (RCTs) where increased dietary intake of omega 3 LCPUFA was compared to placebo or no intervention with the aim of preventing the development of AMD, or slowing its progression. Both authors independently selected studies, assessed them for risk of bias and extracted data. One author entered data into RevMan 5 and the other author checked the data entry. We conducted a meta-analysis for one primary outcome, progression of AMD, using a fixed-effect inverse variance model. We included two RCTs in this review, in which 2343 participants with AMD were randomised to receive either omega 3 fatty acid supplements or a placebo. The trials, which had a low risk of bias, were conducted in the USA and France. Overall, there was no evidence that people who took omega 3 fatty acid supplements were at decreased (or increased risk) of progression to advanced AMD (pooled hazard ratio (HR) 0.96, 95% confidence interval (CI) 0.84 to 1.10, high quality evidence). Similarly, people taking these supplements were no more (or less) likely to lose 15 or more letters of visual acuity (USA study HR 0.96, 95% CI 0.84 to 1.10; French study at 36 months risk ratio (RR) 1.25, 95% CI 0.69 to 2.26, participants = 230). The number of adverse events was similar in the intervention and placebo groups (USA study participants with one or more serious adverse event RR 1.00, 95% CI 0.91 to 1.09, participants = 2080; French study total adverse events RR 1.05, 95% CI 0.97 to 1.13, participants = 263). This review found that omega 3 LCPUFA supplementation in people with AMD for periods up to five years does not reduce the risk of progression to advanced AMD or the development of moderate to severe visual loss. No published randomised trials were identified on dietary omega 3 fatty acids for primary prevention of AMD. Currently available evidence does not support increasing dietary intake of omega 3 LCPUFA for the explicit purpose of preventing or slowing the progression of AMD.

Dietary Supplements and Adverse Events

Scientific evidence suggests that supplementation food [herbal or complementary nutritional products and micronutrients (vitamins and minerals)], can be beneficial to a small group of persons whose diet is not balanced, and has evidence of deficiency of a particular nutrient in the body. However, it has seen an increase in consumption of these supplements in people involved in physical or athletic activity, and also the adverse effects [1-9].

Vitamin E supplementation in people with cystic fibrosis.

People with cystic fibrosis are at an increased risk of fat-soluble vitamin deficiency including vitamin E. Vitamin E deficiency can cause a host of conditions such as haemolytic anaemia, cerebellar ataxia and cognitive difficulties. Vitamin E supplementation is widely recommended in cystic fibrosis and aims to ameliorate this deficiency. To determine the effects of any level of vitamin E supplementation on the frequency of vitamin E deficiency disorders in people with cystic fibrosis. We searched the Cochrane Group's Cystic Fibrosis Trials Register and also searched international trial registers for any ongoing clinical trials that were not identified during our register search.Date of last search of the Register: 10 February 2014. Date of last search of international trial registers: 30 August 2014. Randomised controlled trials and quasi-randomised controlled trials comparing any preparation of vitamin E supplementation to placebo or no supplement, regardless of dosage or duration. Two authors extracted outcome data from each study (published information) and assessed the risk of bias of each included study. Four studies with a total of 141 participants were included in the review, two of these were in children (aged six months to 14.5 years), and the other two did not specify participants' age. All studies used different formulations and doses of vitamin E for various durations of treatment (10 days to six months). Two studies compared the supplementation of fat-soluble as well as water-soluble formulations to no supplementation in different arms of the same study. A third study compared a water-soluble formulation to a placebo; and in the fourth study a fat-soluble formulation of vitamin E was assessed against placebo.At one month, three months and six months, water-soluble vitamin E significantly improved serum vitamin E levels compared with control: at one month, two studies, mean difference 17.66 (95% confidence interval 10.59 to 24.74); at three months, one study, mean difference 11.61 (95% confidence interval 4.77 to 18.45); and at six months, one study, mean difference 19.74 (95% confidence interval 13.48 to 26.00). At one month fat-soluble vitamin E significantly improved serum vitamin E levels compared with control: one month, two studies, mean difference 13.59 (95% CI 9.52 to 17.66). The findings at three months were imprecise; one study; mean difference 6.40 (95% CI -1.45 to 14.25).None of the studies report the review's primary outcomes of vitamin E total lipid ratio or the incidence of vitamin E-specific deficiency disorders, or the secondary outcomes lung function or quality of life. Only one study, comparing water-soluble vitamin E with placebo, reported the secondary outcome of growth and nutritional status (weight), but the results are uncertain due to imprecision around the effect estimate.There was limited detail about randomisation and blinding in the included studies which compromises the quality of the evidence base for the review. The heterogeneous mix of the formulations with differing biovailabilities among these studies also limits the generalisability of the data to the wider cystic fibrosis population. Vitamin E supplementation led to an improvement in vitamin E levels in people with cystic fibrosis, although the studies may have been at risk of bias. No data on other outcomes of interest were available to allow conclusions about any other benefits of this therapy.In future, larger studies are needed, especially in people already being treated with enteric-coated pancreatic enzymes and supplemented with vitamin E, to look at more specific outcome measures such as vitamin E status, lung function and nutritional status. Future studies could also look at the optimal dose of vitamin E required to achieve maximal clinical effectiveness.

Oral calorie supplements for cystic fibrosis.

Poor nutrition occurs frequently in people with cystic fibrosis (CF) and is associated with other adverse outcomes. Oral calorie supplements are used to increase total daily calorie intake and improve weight gain. However, they are expensive and there are concerns they may reduce the amount of food eaten and not improve overall energy intake. To establish whether in people with CF, oral calorie supplements: increase daily calorie intake; and improve overall nutritional intake, nutritional indices, lung function, survival and quality of life. To assess adverse effects associated with using these supplements. We searched the Cochrane CF Trials Register comprising references from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We contacted companies marketing oral calorie supplements.Last search: 03 July 2014. Randomised or quasi-randomised controlled trials comparing use of oral calorie supplements for at least one month to increase calorie intake with no specific intervention or additional nutritional advice in people with CF. We independently selected the included trials, assessed risk of bias and extracted data. We contacted the authors of included trials and obtained additional information for two trials. We identified 21 trials and included three, reporting results from 131 participants lasting between three months and one year. Two trials compared supplements to additional nutritional advice and one to no intervention. Two of the included trials recruited only children. In one trial the risk of bias was low across all domains, in a second trial the risk of bias was largely unclear and in the third mainly low. Blinding of participants was unclear in two of the trials. Also, in one trial the clinical condition of groups appeared to be unevenly balanced at baseline and in another trial there were concerns surrounding allocation concealment. There were no significant differences between people receiving supplements or dietary advice alone for change in weight, height, body mass index, z score or other indices of nutrition or growth. Changes in weight (kg) at three, six and twelve months respectively were: MD 0.32 (95% CI -0.09 to 0.72); MD 0.47 (95% CI -0.07 to 1.02 ); and MD 0.16 (-0.68 to 1.00). Total calorie intake was greater in people taking supplements at 12 months, MD 265.70 (95% CI 42.94 to 488.46). There were no significant differences between the groups for anthropometric measures of body composition, lung function, gastrointestinal adverse effects or activity levels. Oral calorie supplements do not confer any additional benefit in the nutritional management of moderately malnourished children with CF over and above the use of dietary advice and monitoring alone. While nutritional supplements may be used, they should not be regarded as essential. Further randomised controlled trials are needed to establish the role of short-term oral protein energy supplements in people with CF and acute weight loss and also for the long-term nutritional management of adults with CF or advanced lung disease, or both.

Protein supplementation and dietary behaviours of resistance trained men and women attending commercial gyms: a comparative study between the city centre and the suburbs of Palermo, Italy

BackgroundIt is anecdotally recognized that commercial gym users assume supplements in order to improve performance or health. However, dietary behaviours of people and athletes attending commercial gyms have been poorly studied. The exact amount and frequency of dietary supplements consumption are still needed to be investigated. The main purpose of this study is to understand the quantity and quality of food intake, as well as dietary supplementation in people attending commercial gyms. Secondly to compare the city centre and the suburbs of Palermo, Italy.MethodsA face-to-face questionnaire was administered to 561 subjects, 207 from the city centre (CC) and 354 from the suburbs (SB) of Palermo, Italy. Frequency of protein supplements use and association with dietary behaviours were investigated. Subsequently, the frequency distribution was used for demographic assessment.ResultsFrequency of protein consumption was similar in both groups (30% for CC and 28.8% for SB). Males show greater consumption percentages than females (30.5% in males and 6.9% in females). Milk and chicken are the most frequently consumed foods. Data show that non-supplement users (NSU) consume significantly more snacks and bakery products than supplement users (SU) (P < 0.001). While, SU consume significantly higher quantities of vegetables, nuts, fresh fish, eggs and canned tuna (P < 0.001). SU consume less low protein food and higher protein foods than NSU. No differences were found between CC and SB.ConclusionsProtein consumption among commercial gym users is 30% for the CC and 28.8% for the SB. Significant differences were found between CC and SB females, underlining an interesting discrepancy, indicating to dietary supplement industries regarding regional implications. Subjects that use protein supplements also consume larger quantities of high protein food compared to NSU. NSU also eat higher proportions of unhealthy food compared to SU.

Vitamin A supplementation for cystic fibrosis.

People with cystic fibrosis and pancreatic insufficiency are at risk of fat soluble vitamin deficiency as these vitamins (A, D, E and K) are co-absorbed with fat. Thus, some cystic fibrosis centres routinely administer these vitamins as supplements but the centres vary in their approach of addressing the possible development of deficiencies in these vitamins. Vitamin A deficiency causes predominantly eye and skin problems while supplementation of vitamin A to excessive levels may cause harm to the respiratory and skeletal systems in children. Thus a systematic review on vitamin A supplementation in people with cystic fibrosis would help guide clinical practice. To determine if vitamin A supplementation in children and adults with cystic fibrosis:1. reduces the frequency of vitamin A deficiency disorders;2. improves general and respiratory health;3. increases the frequency of vitamin A toxicity. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search of the Group's Cystic Fibrosis Trials Register: 07 April 2014. All randomised or quasi-randomised controlled trials comparing all preparations of oral vitamin A used as a supplement compared to either no supplementation (or placebo) at any dose and for any duration, in children or adults with cystic fibrosis (defined by sweat tests or genetic testing) with and without pancreatic insufficiency. No relevant studies for inclusion were identified in the search. No studies were included in this review. As there were no randomised or quasi-randomised controlled trials identified, we cannot draw any conclusions on the benefits (or otherwise) of regular administration of vitamin A in people with cystic fibrosis. Until further data are available, country or region specific guidelines on the use of vitamin A in people with cystic fibrosis should be followed.

Vitamin D supplementation for cystic fibrosis.

Cystic fibrosis (CF) is a genetic disorder with multiorgan effects. In a subgroup with pancreatic insufficiency malabsorption of the fat soluble vitamins (A, D, E, K) may occur. Vitamin D is involved in calcium homeostasis and bone mineralisation and may have extraskeletal effects. This review examines the evidence for vitamin D supplementation in cystic fibrosis. To assess the effects of vitamin D supplementation on the frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity in the cystic fibrosis population. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search: 08 July 2013. Randomised and quasi-randomised controlled studies of vitamin D supplementation compared to placebo in the cystic fibrosis population regardless of exocrine pancreatic function. Both authors independently assessed the risk of bias of each included study and extracted outcome data (from published study information) for assessment of bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events. Six studies (239 participants) are included, although only three studies provided data from 69 adults and children with cystic fibrosis for analysis. One study compared a single high dose of vitamin D (250,000 IU) to placebo at the time of hospital admission with a respiratory exacerbation in 30 pancreatic insufficient adults with cystic fibrosis. The second study compared supplemental 800 international units (IU) vitamin D and placebo for 12 months in 30 osteopenic pancreatic insufficient adults; both groups continued 900 IU vitamin D daily. The third study compared supplemental 1 g calcium alone, 1600 IU vitamin D alone, 1600 IU vitamin D and 1 g calcium and placebo in a double-blind randomised cross-over study; only nine children who completed both vitamin D and placebo groups after six-months supplementation and a three-month washout period are included; pancreatic sufficiency or disease status of participants are not defined. The studies are not directly comparable due to differences in supplementation, outcome reporting and possibly participant characteristics (e.g. severity of lung disease, growth and nutrition, pancreatic sufficiency).The only outcome for which we could combine data from more than two studies was 25-hydroxyvitamin D levels; patients receiving vitamin D supplementation had significantly higher levels, mean difference 7.24 ng/ml (95% confidence interval 5.01 to 9.46). However, ironically one study reported 1,25(OH)2D with levels significantly favouring the placebo group, mean difference -30.30 pmol/ml (95% confidence interval -59.89 to -0.71). Bone mineral density was measured in two studies; both described no significant change between groups. There were no adverse events in any study.The remaining three studies are published as abstracts only and did not provide data for analysis. These abstracts include: a report of pre-intervention data in a study comparing daily calcitriol (0.25 or 0.5 micrograms) with placebo in pancreatic insufficient children and young adults; an interim report of a double-blind randomised control study comparing 5000 IU vitamin D daily for 12 weeks during winter in 67 adult cystic fibrosis patients; and a comparison of the effect of three months of vitamin D supplementation (dose not specified) with placebo on bone mineral density in 42 children with cystic fibrosis and low bone mineral density.Risk of bias was highly variable between all studies. Only one study had a low risk of bias for the five main criteria (random sequence generation, allocation, blinding, attrition and reporting). The rest of the studies had unclear or high risks of bias. Two studies had a low risk of bias for blinding and another two studies for attrition bias. In the studies published as abstracts, assessment of the risks of bias was uncertain in many aspects. In patients receiving vitamin D supplementation, 25-hydroxyvitamin D levels are significantly higher. However, there is no evidence of clinical benefit or harm in the limited number of small-sized published studies. Adherence to relevant cystic fibrosis guidelines on vitamin D supplementation should be considered until further evidence is available.

Assessment of Vitamin D Supplementation in People with Intellectual Disability

Vitamin D levels are often lower than recommended among certain groups, and these so-called at risk populations include institutionalised people with intellectual disabilities. The administration of vitamin D supplements does normalize these levels, but they tend to fall again when treatment is discontinued. The objectives of this study were, first, to assess whether the administration of 20,000 IU of cholecalciferol monthly and 60,000 IU quarterly over a year provide similar satisfactory results, and second, to explore whether the results are associated with following variables: sex, antiepileptic medication, being a wheelchair user or able to walk, and being a resident or day care user. The study population was composed of 204 individuals of both sexes cared for in four centres of the same institution. There were no differences between the levels reached with monthly and quarterly administration. The overall results show that, at the end of the test period, total 25(OH)vitamin D levels were &lt;30 nmol/L in 3.5% of participants, 30 to &lt; 50 nmol/L in 34%, 50 to &lt;75 nmol/L in 41% and ≥75 nmol/L in 21.5%. There were significant differences between centres. We did not observe any harmful adverse effects attributable to the treatment. To conclude, we propose the continuous systematic administration of 60,000 IU of cholecalciferol every three months in this at-risk population.

Low 25-hydroxyvitamin D levels in people with a solid tumor cancer diagnosis: the tip of the iceberg?

Low serum 25-hydroxyvitamin D [25(OH)D] levels have been linked to both cancer incidence and poor prognosis. The frequency of 25(OH)D tests and clinical factors associated with low levels in cancer patients are unknown. Electronic medical records from 2006 to 2007 of 39,252 adult solid tumor patients were reviewed. Data included demographics, cancer sites (primary and metastatic), and first serum 25(OH)D level during the study period. Laboratory data, comorbidities, selected medications, and anticancer treatment within the prior 2 months were recorded. Data were compared between (1) those tested and not tested and (2) 25(OH)D levels≤10 ng/ml (deficient), 11-30 ng/ml (insufficient), and ≥31 ng/ml (sufficient). Stepwise logistic regression identified independent predictors of low serum 25(OH)D levels. The cohort was 86% Caucasian and 48% female with a mean age of 63±14 years (mean±SD). The most prevalent cancer was breast (19%). In total, 2,098 (5%) had a 25(OH)D test. Of those tested, 133 (6%) had levels≤10 ng/ml and 1,311 (62%) 11-30 ng/ml. Tests were more frequent in females and in those with breast, skin, and thyroid cancers (P<0.001). Low 25(OH)D levels were associated (in univariable analyses) with male gender, non-Caucasian race, gastrointestinal tumor primary sites, metastatic disease, benign liver disease, low serum albumin, and elevated liver enzymes. Significant factors in multivariable models for 25(OH)D levels≤10 and ≤30 ng/ml included non-Caucasian race, primary cancer site, and test calendar month. Vitamin D supplements and recent antineoplastic medication were associated with sufficient levels. Low (deficient or insufficient) 25(OH)D serum levels were highly prevalent in people with solid tumors. Vitamin D tests were infrequent and paradoxically less often done in high-risk groups. Tests were more frequent in females and in those with breast, skin, and thyroid cancers. Further research should examine role of routine 25(OH)D tests, the clinical consequences of low levels, and therapeutic supplementation in people with cancer.

Chromium picolinate supplementation for overweight or obese adults.

Obesity is a global public health threat. Chromium picolinate (CrP) is advocated in the medical literature for the reduction of bodyweight, and preparations are sold as slimming aids in the USA and Europe, and on the Internet. To assess the effects of CrP supplementation in overweight or obese people. We searched The Cochrane Library, MEDLINE, EMBASE, ISI Web of Knowledge, the Chinese Biomedical Literature Database, the China Journal Full text Database and the Chinese Scientific Journals Full text Database (all databases to December 2012), as well as other sources (including databases of ongoing trials, clinical trials registers and reference lists). We included trials if they were randomised controlled trials (RCT) of CrP supplementation in people who were overweight or obese.We excluded studies including children, pregnant women or individuals with serious medical conditions. Two authors independently screened titles and abstracts for relevance. Screening for inclusion, data extraction and 'Risk of bias'assessment were carried out by one author and checked by a second. We assessed the risk of bias by evaluating the domains selection,performance, attrition, detection and reporting bias. We performed a meta-analysis of included trials using Review Manager 5. We evaluated nine RCTs involving a total of 622 participants. The RCTs were conducted in the community setting, with interventions mainly delivered by health professionals, and had a short- to medium-term follow up (up to 24 weeks). Three RCTs compared CrPplus resistance or weight training with placebo plus resistance or weight training, the other RCTs compared CrP alone versus placebo.We focused this review on investigating which dose of CrP would prove most effective versus placebo and therefore assessed the results according to CrP dose. However, in order to find out if CrP works in general, we also analysed the effect of all pooled CrP doses versus placebo on body weight only.Across all CrP doses investigated (200 μg, 400 μg, 500 μg, 1000 μg) we noted an effect on body weight in favour of CrP of debatable clinical relevance after 12 to 16 weeks of treatment: mean difference (MD) -1.1 kg (95% CI -1.7 to -0.4); P = 0.001; 392 participants;6 trials; low-quality evidence (GRADE)). No firm evidence and no dose gradient could be established when comparing different doses of CrP with placebo for various weight loss measures (body weight, body mass index, percentage body fat composition, change in waist circumference).Only three studies provided information on adverse events (low-quality evidence (GRADE)). There were two serious adverse events and study dropouts in participants taking 1000 μg CrP, and one serious adverse event in an individual taking 400 μg CrP. Two participants receiving placebo discontinued due to adverse events; one event was reported as serious. No study reported on all-cause mortality,morbidity, health-related quality of life or socioeconomic effects. We found no current, reliable evidence to inform firm decisions about the efficacy and safety of CrP supplements in overweight or obese adults.

Omega-3 fatty acids for intermittent claudication.

Omega-3 fatty acids have been used in the treatment and prevention of coronary artery disease although current evidence suggests they may be of limited benefit. Peripheral arterial disease and coronary artery disease share a similar pathogenesis so omega-3 fatty acids may have a similar effect on both conditions. This is an update of a review first published in 2004 and updated in 2007. To determine the clinical and haematological effects of omega-3 supplementation in people with intermittent claudication. For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched September 2012) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 9). Randomised controlled trials of omega-3 fatty acids versus placebo or non-omega-3 fatty acids in people with intermittent claudication. One review author identified potential trials. Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information if necessary. Nine studies were included representing 425 participants. All studies compared omega-3 fatty acid supplementation with placebo lasting from four weeks to two years. Three studies with long treatment periods administered additional substances, making any observed effects impossible to attribute to omega-3 fatty acids and were excluded from the statistical analyses. One study did not express any mean values and, therefore, could not be included in statistical analyses.No significant differences between intervention and control groups were observed in pain-free walking distance (mean difference (MD) 11.62 m, 95% confidence interval (CI) -67.74 to 90.98), maximal walking distance (MD 16.99 m, 95% CI -72.14 to 106.11), ankle brachial pressure index (MD -0.02, 95% CI -0.09 to 0.05), total cholesterol levels (MD 0.27 mmol/L, 95% CI -0.48 to 1.01), high-density lipoprotein cholesterol levels (MD 0.00 mmol/L, 95% CI -0.16 to 0.15), low-density lipoprotein cholesterol levels (MD 0.44 mmol/L, 95% CI -0.31 to 1.19), triglyceride levels (MD -0.39 mmol/L, 95% CI -1.10 to 0.33), systolic blood pressure (MD 5.00 mmHg, 95% CI -11.59 to 21.59) or plasma viscosity (MD 0.03 mPa/s, 95% CI -0.02 to 0.08).There was some limited evidence that blood but not plasma viscosity levels decreased with treatment and gastrointestinal side effects such as nausea, diarrhoea and flatulence were observed in two studies. Omega-3 fatty acids appear to have little haematological benefit in people with intermittent claudication and there is no evidence of consistently improved clinical outcomes (quality of life, walking distance, ankle brachial pressure index or angiographic findings). Supplementation may also cause adverse effects such as nausea, diarrhoea and flatulence. Further research is needed to evaluate fully short- and long-term effects of omega-3 fatty acids on the most clinically relevant outcomes in people with intermittent claudication before they can be recommended for routine use.

Zinc supplements for treating thalassaemia and sickle cell disease.

Zinc supplements for treating thalassaemia and sickle cell disease.

Selenium supplementation for Hashimoto's thyroiditis.

Hashimoto's thyroiditis is a common auto-immune disorder. The most common presenting symptoms may include anxiety, negative mood, depression, dry skin, cold intolerance, puffy eyes, muscle cramps and fatigue, deep voice, constipation, slow thinking and poor memory. Clinical manifestations of the disease are defined primarily by low levels of thyroid hormones; therefore it is treated by hormone replacement therapy, which usually consists of levothyroxine (LT4). Selenium might reduce antibody levels and result in a decreased dosage of LT4 and may provide other beneficial effects (e.g. on mood and health-related quality of life). To assess the effects of selenium supplementation on Hashimoto's thyroiditis. We searched the following databases up to 2 October 2012: CENTRAL in The Cochrane Library (2012, Issue 10), MEDLINE, EMBASE, and Web of Science; we also screened reference lists of included studies and searched several online trial registries for ongoing trials (5 November 2012). Randomised controlled clinical trials that assessed the effects of selenium supplementation for adults diagnosed with Hashimoto's thyroiditis. Study selection, data extraction, assessment of risk of bias, and analyses were carried out by two independent review authors. We assessed the quality of the evidence of included studies using GRADE. We were unable to conduct a meta-analysis because clinical heterogeneity between interventions that were investigated is substantial. Four studies at unclear to high risk of bias comprising 463 participants were included. The mean study duration was 7.5 months (range 3 to 18 months). One of our primary outcomes－'change from baseline in health related quality of life'－and two of our secondary outcomes－'change from baseline in LT4 replacement dosage at end of the study' and 'economic costs'－were not assessed in any of the studies. One study at high risk of bias showed statistically significant improvement in subjective well-being with sodium selenite 200 μg plus titrated LT4 compared with placebo plus titrated LT4 (relative risk (RR) 4.67, 95% confidence interval (CI) 1.61 to 13.50; P = 0.004; 36 participants; number needed to treat (NNT) = 2 (95% CI 2 to 3)).Selenomethionine 200 μg reduced the serum levels of anti-thyroid peroxidase antibodies compared with placebo in two studies (mean difference (MD) -917 U/mL, 95% CI -1056 to -778; P < 0.001; 85 participants) and (MD -345 IU/mL, 95% CI -359 to -331; P < 0.001; 169 participants). Pooling of the studies was not feasible due to marked clinical heterogeneity (I(2) = 99%). In a further comparison within the first study where selenomethionine was combined with LT4 the reduction in TPO antibodies was even more noticeable (MD -1508 U/mL, 95% CI -1671 to -1345; P < 0.001; 86 participants). In a third study, where LT4 was added to both intervention arms, a reduction in serum levels of anti-thyroid peroxidase antibodies favoured the selenomethionine arm as well (MD -235 IU/mL, 95% CI -374 to -95; P = 0.001; 88 participants). Although the changes from baseline were statistically significant in these three studies, their clinical relevance is unclear. Serum antibodies were not statistically significantly affected in the study comparing sodium selenite 200 μg plus titrated LT4 with placebo plus titrated LT4 (MD -25, 95% CI -181 to 131; P = 0.75; 36 participants).Adverse events were reported in two studies (1 of 85 and 1 of 88 participants, respectively). Selenium supplementation did not appear to have a statistically significant impact on the incidence of adverse events (RR 2.93, 95% CI 0.12 to 70.00; and RR 2.63, 95% CI 0.11 to 62.95). Results of these four studies show that evidence to support or refute the efficacy of selenium supplementation in people with Hashimoto's thyroiditis is incomplete. The current level of evidence for the efficacy of selenium supplementation in the management of people with Hashimoto's thyroiditis is based on four randomised controlled trials assessed at unclear to high risk of bias; this does not at present allow confident decision making about the use of selenium supplementation for Hashimoto's thyroiditis. This review highlights the need for randomised placebo-controlled trials to evaluate the effects of selenium in people with Hashimoto's thyroiditis and can ultimately provide reliable evidence to help inform clinical decision making.