Patients Receiving Vitamin D3 Research Articles

Impact of Vitamin D3 Supplementation on Recurrent Aphthous Ulcer

Vitamin D is a well-known secosteroid hormone, which exerts multiple essential roles in bone physiology, cell growth and differentiation, the neuromuscular system, immunomodulatory functions and autoimmune diseases. Deficiency of vitamin D has been linked to many oral disorders including tooth decay, periodontitis, oral cancer, oral candidiasis, oral lichen planus and recurrent aphthous ulcers. Many studies have revealed a significant lower serum vitamin D level in recurrent aphthous ulcer patients compared with healthy volunteers. This proposes that vitamin D supplementation may reduce the severity of the lesion. To evaluate the efficacy of vitamin D3 replacement on recurrent aphthous ulcer severity is the objective of the study. This study involved 65 patients with idiopathic minor recurrent aphthous ulcer and vitamin D deficiency/insufficiency. These patients received vitamin D3 supplement over 1 y. Severity of the disease was delineated by the duration of episodes, the number of ulcers per attack and the frequency of recurrence. Severity parameters were compared before and after vitamin D3 intake. In addition, 25-hydroxy vitamin D3 concentrations were measured before and after administration of vitamin D3 by enzyme-linked immunosorbent assay technique. We found a significant decrease in the frequency of attacks and the number of ulcers in each attack with p-value<0.05 following vitamin D replacement. Moreover, a highly significant lowering in the duration of episodes was detected with p-value<0.001. Gender specific analysis showed no statistically significance regarding severity parameters at any point of the study stages. Correlation studies revealed the only detectable correlation was between serum 25-hydroxy vitamin D3 level at baseline and the number of ulcers before and after vitamin D correction. Vitamin D3 supplementation has a safe and positive impact on improving the severity of recurrent aphthous ulcer with regards to the number of lesions, the frequency of recurrence and the duration of episodes, in patients who have vitamin D deficiency/insufficiency.

What is a reasonable rate for specific osteoporosis drug therapy in older fragility fracture patients?

Osteoporosis is the most common condition contributing to 95% of fractures in older patients hospitalized for fracture treatment. Despite the significant impact of fragility fractures on patient morbidity and mortality, efforts in optimizing osteoporotic treatment and prevention remain inadequate. In contrast, in patients with limited life expectancy, withholding specific osteoporosis drug treatment appears reasonable. The threshold between under- and overtreatment is still unclear. In 2016, we implemented a fracture liaison service (FLS) for 18months to improve the quality of osteoporosis care. We collected prospectively the patient's history, current treatment for osteoporosis, and risk factors for fragility fractures using a standardized protocol. Recommendations for drug therapy are discussed during the interdisciplinary ward round. The primary outcome parameter was a recommendation for specific osteoporosis drug treatment. We included 681 patients (mean age 82.5years, 502 (73.7%) females). The inclusion criteria were the following: age of 70years or older, admission to geriatric fracture center between April 2016 and December 2018. Based on our data, specific osteoporosis drug therapy was recommended in 467 (68.6%) patients. Six hundred fifty-one (95.6%) patients received vitamin D3, and 546 (80.2%) calcium. After adjustment, only age (every 5years, OR 0.57; 95% CI 0.45-0.72; p < 0.0001), cognitive impairment (OR 0.41; 95% CI 0.23-0.74; p = 0.003), pre-fracture mobility (OR 1.54; 95% CI 1.34-1.75; p < 0.0001), and living in a nursing home (OR 0.52; 95% CI 0.27-0.99; p = 0.049) remained as independent predictors for an indication of specific osteoporosis drug therapy. We found a higher rate of recommendations for specific osteoporosis drug therapy compared with usual treatment rates in literature. Though in some cases withholding of specific osteoporosis drug therapy seems reasonable, the main proportion of fragility fracture patients is undertreated. Our results could be a benchmark for the quality of osteoporosis care in older fragility fracture patients treated in a geriatric fracture center.

Vitamin D3 might improve headache characteristics and protect against inflammation in migraine: a randomized clinical trial.

Due to anti-inflammatory effects of vitamin D3, we aimed to explore the effects of supplementation with this vitamin on headache characteristics and serum levels of pro/anti-inflammatory markers in migraineurs. This placebo-controlled, double-blind study included 80 episodic migraineurs who randomly assigned into two equal groups to receive either daily dose of vitamin D3 2000 IU (50μg) or placebo for 12weeks. At baseline and after the trial, headache characteristics were determined using diaries and serum levels of interleukin (IL)-10, IL-6, inducible nitric oxide synthase (iNOS), and cyclooxygenase-2 (Cox-2) were assessed via ELISA method. At the end of trial, analysis of covariance (ANCOVA) adjusted for baseline values, and confounders revealed that vitamin D3 supplemented group experienced significantly lower headache days per month (4.71), reduced attacks duration (12.99h/attack), less severe headaches (5.47, visual analog scale), and lower analgesics use/month (2.85) than placebo group (6.43, 18.32, 6.38 and 4.87, respectively) (P values < 0.05). Using ANCOVA adjusted for baseline levels and confounding variables, it was found that serum levels of IL-10 and Cox-2 did not significantly differ between groups after the experiment; whereas, iNOS serum level was significantly reduced in the intervention group (106.06U/L) comparing to the controls (156.18U/L P : 0.001). Also, the patients receiving vitamin D3 yielded a marginally significant lower IL-6 serum concentration (76.43ng/L) compared to placebo (93.10ng/L) (P value:0.055). Based on the results of this study, we found that 2000IU (50μg)/day vitamin D3 supplementation for 12weeks could improve headache characteristics and might reduce neuro-inflammation in episodic migraine.

Comparative evaluation of crestal bone level in patients having low level of Vitamin D treated with dental implant with or without Vitamin D3 supplements.

Introduction: Vitamin D has been shown to play a vital role in bone mineral homeostasis by stimulating the intestinal absorption of calcium and phosphate. The critical role of Vitamin D in bone metabolism triggered the need to evaluate the effect of Vitamin D deficiency and hence replacement of the same on osseointegration of dental implants. This prospective study evaluated the crestal bone level in patients having low level of Vitamin D treated with dental implant with or without Vitamin D3 supplements.Materials and Methods: A prospective clinical study was conducted on 32 patients based on the inclusion and exclusion criteria. Patients were divided into two groups on the basis of Vitamin D level < 30 ng/ml (Group I: patients receiving Vitamin D3 supplements, i.e., cholecalciferol 1 g sachet 60,000 IU/month) or <30 ng/ml (Group II: not receiving Vitamin D3 supplements). The crestal bone level measurements were made with the help of Digimizer Image Analysis, MedCalc software.Results: All implants showed clinically acceptable crestal bone level at interval of 1 week (baseline), 3 months, and 6 months. There was a statistically nonsignificant difference seen for the values between the groups (P > 0.05) for all other values at various time intervals. However, there was a statistically significant/highly significant difference seen for the values between the groups (P < 0.01, 0.05) for 3 months distal with higher values for Group I as compared to Group II.Conclusion: From the study, it can be concluded that cholecalciferol has systemic effects on accelerating bone formation around titanium implant.

Vitamin D deficiency and supplementation in patients with aggressive B-cell lymphomas treated with immunochemotherapy.

Vitamin D deficiency has been reported to be a negative prognostic factor in elderly patients with aggressive B‐cell lymphomas. In vitro data suggest that vitamin D supplementation may enhance rituximab‐mediated cytotoxicity. We prospectively assessed 25‐hydroxyvitamin D [25(OH)D] levels at diagnosis in a cohort of 155 patients with aggressive B‐cell lymphomas of whom 128 had diffuse large B‐cell lymphoma (DLBCL) not otherwise specified. 25(OH)D levels were deficient (<20 ng/mL) in 105 (67%), insufficient (20–29 ng/mL) in 32 (21%), and normal (≥30 ng/mL) in 18 (12%) patients with a seasonal variation. Patient characteristics associated with lower 25(OH)D levels were poor performance status, overweight, B‐symptoms, elevated LDH, lower albumin and hemoglobin levels. As a result of a change in practice pattern, 116 patients received vitamin D3 (cholecalciferol) supplementation that included a loading phase with daily replacement and subsequent maintenance phase with a weekly dose of 25,000 IU until end of treatment. This resulted in a significant increase in 25(OH)D levels, with normalization in 56% of patients. We analyzed the impact of 25(OH)D levels on event‐free survival in patients treated with Rituximab‐CHOP. 25(OH)D levels below 20 ng/mL at diagnosis and IPI were independently associated with inferior EFS. Moreover, patients with normalized 25(OH)D levels following supplementation showed better EFS than patients with persistently deficient/insufficient 25(OH)D levels. Our study provides the first evidence that achievement of normal 25(OH)D levels after vitamin D3 supplementation is associated with improved outcome in patients with DLBCL and deficient/insufficient 25(OH)D levels when receiving rituximab‐based treatment.

Effect of Vitamin-D Supplement in Patients Diagnosed as Chronic Rhinosinusitis with Vitamin-D Deficiency

Introduction: Rhinosinusitis is a heterogeneous disease characterized by local inflammation of the upper airways and sinuses. The pathogenesis of chronic rhino sinusitis remains poorly defined. It was recently proposed that Vitamin D deficiency may explain some part of this pattern. The aim of study is to evaluate the effect of vitamin D supplement in patients diagnosed as chronic rhino sinusitis with vitamin D deficiency. Materials and Methods: Prospective study was performed on 57 patients diagnosed as chronic Rhinosinusitis and vitamin D deficiency. Patients received vitamin D3 tablet (1000 IU) daily for one month. Before and after drug intake all patients were asked to fill in a questionnaire in which they rated their overall symptoms. Results: (75.4%) of patients cured from smell disturbance, (22.8%) of patients cured from headache, (21.1%) cured from nasal obstruction and only 7% of patients cured from nasal discharge. (64%) of patients improve (not cured) from nasal obstruction symptoms, (63%) of patients not cure from nasal discharge. Conclusions: Vitamin D supplement shows significant improvement in symptoms of chronic Rhinosinusitis mainly smell disturbance, Vitamin D could be use as adjuvant treatment for Chronic Rhino sinusitis.

Vitamin D supplementation and systemic inflammation in relapsing-remitting multiple sclerosis.

Observational studies have suggested that vitamin D may reduce inflammation in relapsing-remitting multiple sclerosis (RRMS), but this has not been clearly confirmed in randomized controlled trials. To further explore the possible anti-inflammatory effects of vitamin D in RRMS, we examined the effect of high-dose oral vitamin D3 on eleven markers of systemic inflammation in 68 RRMS patients enrolled in a double-blinded randomized placebo-controlled trial of vitamin D3 supplementation (20,000IU/week) (NCT00785473). Serum inflammation markers and 25-hydroxyvitamin D (25(OH)D) were measured at baseline and week 96, and no restrictions were set on additional standard immunomodulatory treatment for RRMS. The mean 25(OH)D level rose from 56±29 to 123±34nmol/L among patients receiving vitamin D3 supplementation, whereas only a minor increase from 57±22 to 63±24nmol/L was seen in the placebo group. However, no significant differences appeared between the vitamin D group and the placebo group for any of the inflammation markers. Patients on immunomodulatory therapy had significantly higher levels of interleukin-1 receptor antagonist and chemokine (C-X-C motif) ligand 16 than patients without immunomodulatory treatment, but there were no clear synergistic effects between immunomodulatory therapy and vitamin D3 supplementation on any of the inflammation markers. The rise in 25(OH)D levels after vitamin D3 supplementation was unaffected by immunomodulatory treatment. We conclude that in this study of RRMS patients, high-dose oral vitamin D3 supplementation prominently increased serum 25(OH)D levels without affecting markers of systemic inflammation, while a more anti-inflammatory phenotype was found among patients on immunomodulatory treatment.

Effect of vitamin D on clinical and biochemical parameters in polycystic ovary syndrome women: A meta-analysis.

Using a meta-analysis framework, we investigated the association between the serum level of vitamin D and the risk of polycystic ovary syndrome (PCOS) and further examined the therapeutic effect of vitamin D on the clinical features of PCOS. Multiple databases were searched to retrieve studies. We chose clinical studies that investigated the relation between the serum level of vitamin D and the risk of PCOS or the therapeutic effect of vitamin D on PCOS. The search results were screened according to strict inclusion and exclusion criteria to select high-quality studies for inclusion. Statistical analyses were carried out using stata 12.0. Seventeen studies were eligible in this meta-analysis. The levels of 25-hydroxyvitamin D and the quantitative insulin-sensitivity check index in the PCOS group were remarkably lower than in the controls, whereas the homeostasis model assessment of insulin resistance in the PCOS group was markedly higher than in the controls. No statistically significant difference was observed in serum parathyroid hormone levels between the two groups. The 25-hydroxyvitamin D levels were significantly elevated after PCOS patients received vitamin D3 treatment, but serum parathyroid hormone concentration, homeostasis model assessment of insulin resistance and quantitative insulin-sensitivity check index did not show any significant changes, indicating a lack of therapeutic response. Our results suggest that the serum level of vitamin D is associated with the risk of PCOS, but the therapeutic effect of vitamin D on PCOS remains to be further explored.

Effectiveness of vitamin D3 in severe persistent asthmatic patients: A double blind, randomized, clinical study.

Objective:To assess the pulmonary function and quality of life in asthma patients receiving vitamin D3 supplementation with inhaled budesonide and formoterol.Materials and Methods:This was a double blinded, randomized, comparative study. Patients were recruited as per the study criteria and randomized into two groups: usual care group (n = 69) patients received budesonide (800 μg) with formoterol (24 μg) and intervention care group (n = 72) patients received vitamin D3 (1000 IU) supplementation along with budesonide (800 μg) plus formoterol (24 μg) for a period of 6 months.Results:A total of 140 patients completed the study. Significant within-group improvement and non-significant between-group improvement is observed with respect to FEV1. In terms of health-related quality of life, within-group comparison revealed a significant (P < 0.05) improvement in all the domains of SGRQ. However, between-group comparisons showed statistically significant (P < 0.05) improvement in symptom, impact and total scores.Conclusion:On the basis of our findings, we conclude that supplementation of vitamin D3 is effective in improving the quality of life rather than pulmonary function in severe asthmatics. However, further studies are warranted to substantiate the present findings.

Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus.

Vitamin D modulates the immune response and blocks induction of an interferon (IFN) signature by systemic lupus erythematosus (SLE) sera. This study was undertaken to investigate the effects of vitamin D supplementation on the IFN signature in patients with SLE. SLE patients (n = 57) with stable, inactive disease, a serum 25-hydroxyvitamin D (25[OH]D) level ≤20 ng/ml, an elevated anti-double-stranded DNA antibody level, and an IFN signature (as determined by measuring the expression levels of 3 IFN response genes) were randomized into a 12-week double-blind, placebo-controlled trial of vitamin D3 at doses of 2,000 IU or 4,000 IU. An IFN signature response was defined as a 50% reduction in the expression of 1 of the 3 genes or a 25% reduction in the expression of 2 of the 3 genes. Disease activity, adverse events, and endocrine effects were assessed. Baseline characteristics of the patients in the 3 treatment groups (placebo, low-dose vitamin D3 , or high-dose vitamin D3 ) were similar. Repletion of 25(OH)D (i.e., levels ≥30 ng/ml) was not observed in any of the patients who were receiving placebo, while repletion was observed in 16 of 33 patients receiving vitamin D3 . The percentage of patients with an IFN signature response did not differ among the treatment groups. Moreover, there was no difference in the percentage of patients with an IFN signature response between those who remained vitamin D deficient and those who demonstrated repletion of vitamin D. Modular microarray analysis of a subset of patients (n = 40) did not reveal changes from baseline in any modules (including the IFN-inducible module) in any of the treatment groups, and no differences in expression were found between patients who demonstrated vitamin D repletion and patients who were persistently vitamin D deficient. Vitamin D3 was well tolerated, and there were no safety concerns. Vitamin D3 supplementation up to 4,000 IU daily was safe and well-tolerated but failed to diminish the IFN signature in vitamin D-deficient SLE patients. Higher 25(OH)D levels sustained for a longer duration may be required to affect immunologic outcomes.

Effect of vitamin D supplementation alone on muscle function in postmenopausal women: a randomized, double-blind, placebo-controlled clinical trial.

The present study investigates the effects of vitamin D on muscle function in postmenopausal women. It has been shown that vitamin D supplementation in postmenopausal women with hypovitaminosis D provides significant protective factor against sarcopenia, with significant increases in muscle strength and control of progressive loss of lean mass. We aimed to evaluate the effect of supplementation of vitamin D (VITD) alone on muscle function in younger postmenopausal women. In this double-blind, placebo-controlled clinical trial, 160 Brazilian postmenopausal women were randomized into two groups: VITD group consisting of patients receiving vitamin D3 1000 IU/day orally (n = 80) or placebo group (n = 80). Women with amenorrhea for more than 12 months and age 50-65 years, with a history of falls (previous 12 months), were included. The intervention time was 9 months, with assessments at two points, start and end. Lean mass was estimated by total-body dual-energy X-ray absorptiometry (DXA) and muscle strength by handgrip strength and chair rising test. The plasma concentrations of 25-hydroxyvitamin D [25(OH)D] were measured by high-performance liquid chromatography (HPLC). Statistical analysis was by intention to treat (ITT), using ANOVA, Student's t test, and Tukey's test. After 9 months, average values of 25(OH)D increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/ml (+45.4%) in the VITD group and decreased from 16.9 ± 6.7 to 13.8 ± 6.0 ng/ml (-18.5%) in the placebo group (p < 0.001). In the VITD group, there was significant increase in muscle strength (+25.3%) of the lower limbs by chair rising test (p = 0.036). In women in the placebo group, there was considerable loss (-6.8%) in the lean mass (p = 0.030). The supplementation of vitamin D alone in postmenopausal women provided significant protective factor against the occurrence of sarcopenia, with significant increases in muscle strength and control of progressive loss of lean mass.

Research in brief

In the first of a pair of randomised, double-blind, placebo-controlled trials published in The Lancet, investigators of the TESLA Part B study assessed the efficacy of the PCSK9 antibody, evolocumab, for homozygous familial hypercholesterolaemia. Patients received monthly evolocumab (n=33) or placebo (n=16) for 12 weeks. The percentage change in ultracentrifugation LDL cholesterol from baseline to week 12 was −23·1% (95% CI −30·7 to −15·4) in the intervention group compared with 7·9% (−2·7 to 18·5) in the placebo group (treatment difference −30·9%, −43·9 to −18·0; adjusted p<0·0001). In the second study, the RUTHERFORD-2 trialists allocated patients with heterozygous familial hypercholesterolaemia to evolocumab (n=110) or placebo (n=54) once every 2 weeks, or monthly evolocumab (n=110) or placebo (n=55), for 12 weeks. Both doses of the study drug led to reductions in LDL cholesterol from baseline to week 12 compared with placebo (treatment difference for once every 2 weeks dose −59·2% [95% CI −65·1 to −53·4] and for the monthly dose −61·3% [–69·0 to −53·6]; p<0·0001 for both). Treatment was generally well tolerated. The CALORIES trial investigators have attempted to resolve the uncertainty regarding the delivery route for early nutritional support in critical care. Their pragmatic, open, multicentre, randomised trial included patients with an unplanned admission to ICU who required early nutritional support. Parenteral or enteral nutrition was administered for up to 5 days. 30 day mortality was 33% (393/1188) in patients allocated to parenteral nutrition and 34% (409/1195) in patients allocated to enteral nutrition; the difference between the groups was not statistically significant (absolute difference between groups 1·15, 95% CI −2·65 to 4·94). Incidence of hypoglycaemia and vomiting was lower in the parenteral group than in the enteral group. A phase 2 randomised dose-ranging trial of mirogabalin has yielded some promising results for people with diabetes and painful peripheral neuropathy. Investigators allocated 452 patients with type 1 or type 2 diabetes and painful peripheral neuropathy to placebo, five different doses of mirogabalin, or pregabalin (active comparator) for 5 weeks. Higher mirogabalin doses (15 mg/day, 20 mg/day, and 30 mg/day) were associated with significantly greater reductions in mean daily pain score from baseline to week 5 compared with placebo (least squares mean difference −0·94, −0·88, and −1·01, respectively; p<0·05). The most common adverse events associated with mirogabalin treatment were dizziness and somnolence. The ADVANCE-ON collaborators report the post-trial observational follow-up of 8494 patients with type 2 diabetes who had participated in the ADVANCE factorial trial. In the ADVANCE trial, although the combination of perindopril and indapamide for blood pressure lowering over 4·5 years was associated with a reduction in mortality, intensive glycaemic control over 5 years was not. In ADVANCE-ON, after 5·9 years post-trial follow-up, reductions in cardiovascular mortality (hazard ratio 0·88, 95% CI 0·77 to 0·99) and all-cause mortality (0·91, 0·84 to 0·99) persisted for the active blood pressure lowering treatment group. There were no differences in cardiovascular mortality or all-cause mortality between the intensive glycaemic control or standard care cohorts after 5·4 years of post-trial follow-up. Liraglutide treatment could have effects beyond glycaemic control alone, suggest the investigators of the LIBRA placebo-controlled trial. Researchers randomly assigned patients with type 2 diabetes to 48 weeks of daily placebo injection (n=25) or subcutaneous liraglutide (n=26). In advance of receiving treatment, all patients had 4 weeks of short-term intensive insulin treatment to improve glucotoxicity caused by diabetes. At 48 weeks, patients in the liraglutide cohort had better pancreatic β-cell function than those in the placebo group, as assessed by the Insulin Secretion-Sensitivity Index-2 (mean [SE] baseline adjusted values: 339·8 [27·8] and 229·3 [28·4], respectively; p=0·008). However, the beneficial effect on β cells was not maintained following termination of liraglutide treatment. Results from a single-centre randomised controlled trial cast the spotlight on the role of vitamin D in intensive care. Investigators for the VITdAL-ICU trial allocated critically ill patients with vitamin D deficiency to receive a loading dose of vitamin D3 (540 000 IU) or placebo, and then five, monthly, maintenance doses. The primary outcome did not differ between groups assigned to vitamin D3 (n=237) or placebo (n=238), with patients receiving vitamin D3 staying in hospital for a median of 20·1 days (IQR 11·1–33·3), and placebo patients for 19·3 days (11·1–34·9; p=0·98). Length of ICU stay, in-hospital death, and death at 6 months did not significantly differ between the two groups.

Effect of vitamin D3 on mild to moderate persistent asthmatic patients: A randomized controlled pilot study.

Background:Asthma is a common chronic inflammatory disease of the bronchial airways. Well defined treatment options for asthma are very few. The role of vitamin D3 on asthma is still baffling. Aim: We have examined the effect of vitamin D3 supplementation in mild to moderate persistent asthma patients.Materials and Methods:We conducted an open labeled, randomized comparative trial in 48 asthma patients. The study duration was about 90 days. The study had a run-in-period of 2 weeks. At the end of run-in-period, patients were divided into two groups: Usual care group (n = 31) patients received budesonide and formoterol and intervention care group (n = 32) patients received vitamin D3 supplementation along with their regular medicine.Results:The primary outcome of the study was to measure the improvement in forced expiratory volume in 1 second (FEV1). Patients in both groups had a significant improvement in FEV1 at the end of the study. The mean difference in percentage predicted FEV1 in usual care and intervention care group was 4.95 and 7.07 respectively.Conclusion:The study concluded that adjunctive therapy of vitamin D3 is effective in asthma patients. The present study will be an evidence based report; however, future studies are warranted in longer duration of time to substantiate the present findings.

OP0247 Effects of Odanacatib on BMD and Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with Alendronate– a Randomized Placebo-Controlled Trial

BackgroundOdanacatib (ODN) is an orally-active cathepsin K inhibitor being developed for the treatment of postmenopausal osteoporosis.ObjectivesThis study evaluated the effects of ODN 50mg once weekly on BMD, bone turnover markers...

Effect of vitamin D3 treatment on bone density in neurofibromatosis 1 patients: A retrospective clinical study

ObjectivesWe have previously demonstrated reduced bone density and an increased incidence of 25-hydroxy vitamin D3 (25-OH D3) deficiency in adults with neurofibromatosis 1 (NF1) compared to healthy controls. Vitamin D3 is a cheap, safe, and effective supplement in the general population, but its value in NF1 patients has not been demonstrated. This study investigates the therapeutic potential of oral vitamin D3 on bone mineral density (BMD) in NF1 patients with vitamin D3 deficiency. MethodsWe measured serum 25-OH D3, parathyroid hormone, calcium, and bone alkaline phosphatase concentrations, urinary deoxypyridinoline concentrations, and BMD in 35 adults with NF1. Nineteen patients received vitamin D3 supplementation for 2 years, six patients received supplementation for 1 year and 10 patients received no supplementation. Supplementation was administered in a dose that maintained the serum 25-OH D3 level above 30μg/l. BMD was measured again at 1 and 2 years, and biochemical assessments of bone metabolism were measured at least every half year during therapy. ResultsTreated subjects had significantly reduced loss of BMD, as measured by T score at the hip (p=0.011) and lumbar spine (p=0.022). The effect on hip BMD was apparent at 1 year in comparison to baseline (p=0.02) and was greater at 2 years in comparison to measurements at 1 year (p=0.02). ConclusionsVitamin D3 supplementation improves BMD in adult NF1 patients. Further studies are needed to elucidate the mechanisms responsible for reduced BMD in NF1 patients.

Vitamin D Status and Response to Daily 400 IU Vitamin D3 and Weekly Alendronate 70 mg in Men and Women with Osteoporosis

Suboptimal vitamin D status is common in elderly individuals. However, the extent of vitamin D inadequacy in men and women being treated for osteoporosis in a family practice setting has not been well characterized. To describe the distribution of serum 25-hydroxyvitamin D (25-[OH] D) in Canadian men and postmenopausal women with osteoporosis taking 400 IU or less of vitamin D daily and to evaluate the safety, tolerability, and impact of vitamin D(3) supplementation 400 IU daily taken concurrently with alendronate sodium 70 mg weekly. This was a prospective, single-cohort, open-label, multicenter study. Community-dwelling men and postmenopausal women with osteoporosis were recruited at 197 sites across Canada. Patients received vitamin D(3) 400 IU/day supplementation coadministered with alendronate 70 mg/wk for 16 weeks. The primary outcome was the distribution of serum 25-(OH) D at baseline. Secondary outcome measures included changes from baseline in serum 25-(OH) D levels, adherence to study treatments, and incidence of treatment-related adverse events (AEs). Of the 681 patients included in the analysis, 485 (71.2%) completed the study. Patients were predominantly female (83.1%) with a mean (SD) age of 67.6 (10.7) years. At baseline, mean (SD) serum 25-(OH) D concentration was 25.4 (9.9) ng/mL and 68.0% of the patients had inadequate (less than 30 ng/mL) vitamin D status. At week 16, concentrations increased by 35.1% to 31.2 (9.2) ng/mL (p < 0.001) and the proportion of patients with inadequate 25-(OH) D levels was reduced to 47.0%. Adherence to the treatment regimen was high (greater than 95%). Gastrointestinal disorders were the most frequently reported (6.9%) treatment-related AEs. About two thirds of patients previously diagnosed with osteoporosis have inadequate vitamin D status. A treatment regimen consisting of alendronate 70 mg/wk administered with daily vitamin D(3) 400 IU supplementation significantly increased patients' serum 25-(OH) D levels, but 47% did not achieve optimal levels. These results support both the National Osteoporosis Foundation and Osteoporosis Canada recommendations for higher vitamin D supplement doses (at least 800 IU daily) in osteoporotic patients receiving pharmacologic therapy for osteoporosis and for monitoring their serum 25-(OH) D response.

Effectiveness of recombinant human erythropoietin, vitamin D3and iron therapy on long-term survival of patients with end-stage renal disease receiving haemodialysis: analysis of 702 patients after 10-year follow-up

Few studies have been conducted to investigate the influence of recombinant human erythropoietin (rhEPO) on the long-term prognosis of end-stage renal disease (ESRD). A retrospective cohort study. The largest regional hospital renowned for haemodialysis in northern Taiwan. A total of 702 ESRD patients undergoing haemodialysis between 1993 and 2002 were evaluated. The rate of overall use of rhEPO, vitamin D3 or Fe therapy was 62 %. The 10-year survival rate in patients with rhEPO supplementation was statistically more favourable than that in patients without rhEPO (hazard ratio (HR) = 0.38, 95 % CI 0.30, 0.47, P < 0.0001). Similar findings were noted for patients receiving vitamin D3 (HR = 0.36, 95 % CI 0.21, 0.64, P = 0.0004) and Fe (HR = 0.45, 95 % CI 0.33, 0.61, P < 0.0001). After adjusting for age, education and aetiology, the administration of rhEPO resulted in statistically significant improvements in long-term survival rate either with (HR = 0.30, 95 % CI 0.22, 0.42) or without (HR = 0.48, 95 % CI 0.38, 0.61) combined use of Fe or vitamin D3. We demonstrated a reduction in long-term mortality related to supplementation therapy with rhEPO, vitamin D3 and Fe. The findings provide a justification for the administration of combined supplement therapy in patients undergoing haemodialysis.

Vitamin D3 and psoriasis: A randomized double-blind placebo-controlled study

A few open studies on small groups of patients have reported the efficacy of oral vitamin D3 in the treatment of psoriasis. To further characterize the therapeutic potential of this agent a placebo-controlled double-blind study was undertaken on a larger group of patients. Vitamin D3 (the active 1-α-hydroxy form) 1 μg/day and a placebo in a similar presentation were given in coded vials to 50 patients. Slight improvement was observed in 9 (45%) patients receiving vitamin D3 and 8 (38%) patients receiving placebo showed similar improvement, indicating that this regimen is not effective in the treatment of moderate to severe psoriasis.

25-Hydroxyvitamin D levels in patients treated with high-dosage ergo- and cholecalciferol.

25-Hydroxyvitamin D (25-OHD) levels were measured in 39 patients with metabolic bone disease or hypoparathyroidism who had been treated with a constant high dose of vitamin D2 or D3 for at least 12 weeks. Plasma 25-OHD levels rose with increasing dosage, the relationship between dose and plasma level being approximately linear whether or not the dose was expressed on a weight-corrected basis. A therapeutic range of 25-OHD to be expected when patients with these conditions are treated with vitamin D has been established. There may be certain exceptions in which plasma 25-OHD levels within the range are associated with either an inadequate response to treatment or, conversely, the hypercalcaemia of vitamin D toxicity. There was no correlation between plasma calcium level and 25-OHD concentration in the group of patients studied. There was also no difference between the dose/25-OHD relationship of patients treated with vitamin D2 and that of patients receiving vitamin D3. Ten patients were started on treatment with large doses of vitamin D during the period of the study. The rate of rise of plasma 25-OHD was followed during treatment. The incremental rise in 25-OHD was calculated at the end of the first week of treatment in terms of dose per unit body weight. The rate of rise of plasma 25-OHD level was highly correlated with the dose used. Plasma 25-OHD levels after one weeks' treatment were only 15-20% of the expected steady-state level on the same dosage. The importance of a high priming dose when a rapid response is needed is thus emphasised.