IU Vitamin D3 Research Articles

Effects of a single dose of vitamin D in septic children: a randomized, double-blinded, controlled trial.

ObjectiveTo assess the effects of a single dose of vitamin D on 25-hydroxyvitamin D (25OHD) levels and clinical outcomes in children with vitamin D deficiency (VDD) and sepsis.MethodsIn this randomized, controlled trial, eligible children with VDD and sepsis were assigned to receive one dose of 150,000 IU of cholecalciferol or placebo. Serum concentrations of 25OHD, angiotensin-II (Ang-II), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were assessed at baseline and 8 days after treatment. The cardiovascular Sequential Organ Failure Assessment (cv-SOFA) score, septic shock incidence, duration of ventilation, and mortality were also examined.ResultsOne hundred nine participants fulfilled the study requirements. The two groups had comparable baseline characteristics. Ang-II, IL-6, and TNF-α concentrations were all reduced after vitamin D supplementation. Furthermore, the cv-SOFA score (1.76 ± 0.8 vs. 2.3 ± 1.1) and incidence of septic shock (7% vs. 20%) were lower in the treatment group than in the control group. The duration of ventilation and mortality rates did not differ between two groups.ConclusionsA single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.

P1410IMPACT OF VITAMIN D SUPPLEMENTATION ON CKD-MBD HEMODIALYSIS PATIENTS - A PROSPECTIVE STUDY

Abstract Background and Aims There are evidences suggesting that 50-90% of hemodialysis (HD) patients are vitamin D deficient [25(OH) D level <20 ng/mL] or insufficient (between 21 to 29 ng/mL). Recent guidelines recommend evaluation and supplementation low serum vitamin D levels in HD patients. However the effects of supplementation remains uncertain. Our aim was to evaluate the effect of supplementation on phosphocalcic metabolism and secondary hyperparathyroidism in HD patients of a hospital unit. Method Prospective study with an 18 months follow-up period. HD patients were supplemented with 12000 IU cholecalciferol 3 times a week if vitamin D level under 30ng/mL and 4000 IU if above. Every 6 months (3 time points) vitamin D, bone alkaline phosphatase (AF), calcium (Ca2+), phosphorus (P+) and intact parathyroid hormone (iPTH) blood levels were measured. Demographic, analytical and clinical data, including diabetic status, were analyzed. Categorical variables are presented as frequencies and percentages, continuous variables as means and standard deviations, or medians and interquartile ranges (IQR) for variables with skewed distributions. Statistical analysis was performed using SPSS version 21 for Windows. Results Sixty patients completed the follow-up period. The average was 74.70±1.43 years, 65% (n=39) were male and 41.7% (n=25) were diabetic. The average HD time at point 3 (18 months) was 3.15±3.62 years. A repeated measures ANOVA with a Greenhouse-Geisser correction showed that cholecalciferol supplementation significantly changed vitamin D blood levels along time (F(2.492;144.54)=26.832; p<0.001), with a statistically significant increase in vitamin D blood levels from time point 0 to point 3 (+8.27 ng/mL, p<0.001). There was also a significant reduction of phosphorus (-0.53mg/dL, p=0.017) and iPTH blood levels (-144.09 pg/nL p<0.001) in the same period. Seric calcium had a statistically significant increase from point 0 to 2 (+0.22 mg/dL, p=0.038). Using Pearson’s correlation, from point 0 to 3, we found a negative correlation between vitamin D and iPTH blood levels variation (Rs= -0.303, p=0.018) and a positive correlation between vitamin D and AF blood levels variation (Rs= 0.043, p=0.002). Conclusion Oral cholecalciferol supplementation increases significantly vitamin D blood levels and can be a good option in the management of secondary hyperparathyroidism and hypocalcemia. However, one of the limitations of our study was not to evaluate the use of medication such as P+ chelating agents and the small sample size. Therefore, large randomized clinical trials with clinically meaningful endpoints (fracture, hospitalization, parathyroidectomy, death) are still required to assess the usefulness of different vitamin D compounds for CKD and dialysis patients.

A 16-week Randomized Controlled Trial of a Fish Oil and Whey Protein-Derived Supplement to Improve Physical Performance in Older Adults Losing Autonomy – A Pilot Study

Abstract Objectives Loss of autonomy is often the trigger for institutionalization of older adults. A nutritional intervention within a rehabilitation program may attenuate loss of muscle mass and function to enable continued autonomy in this understudied group of seniors. Objectives: 1) To assess the feasibility of a combined nutrient supplementation intervention with regards to recruitment, compliance, and completion of assessments in older adults losing autonomy; 2) to characterize this specific population. Methods Seniors taking part in a rehabilitation program were randomized to an intervention with a supplement (EXP: 2 g fish oil (EPA+ DHA) with 1500 IU vitamin D3 1x/d+ 20–30 g whey protein powder with 3 g leucine 2x/d) or placebo (CTR; corn oil and maltodextrin powder) for 16 weeks. Lean soft tissue mass (LM) and physical function were assessed. LM (DXA) was measured at weeks 0 and 16, handgrip and knee extension strength (dynamometry), physical performance tests and plasma phospholipid n-3 fatty acids (GCMS) were evaluated at weeks 0, 8 and 16. Results Over 2 y, 244 patients were screened, 46 were eligible (18.9%; 95% CI: 15.0, 22.8), 20 were randomized, 10 completed the study (n = 4 in EXP; n = 6 in CTR). Median age was 87 y (77–94 y; 75% women), 35% had low LM, 35% were frail, 85% were using a walking aid daily and physical performance was low, at baseline. Overall self-reported compliance to powder was 96% (95% CI: 83, 108) and to oil, 85% (95% CI: 63, 107). The EXP median protein intake alone surpassed the target 1.2–1.5 g/kg/d for older adults, without altering usual diet. Proportions of EPA and DHA increased significantly 3- and 1.5-fold respectively at week 8 in EXP, with no change in CTR. Participants were able to complete most assessments with sustained guidance. Conclusions Because of low eligibility limiting the pool of potential patients, the pilot study was interrupted as deemed non-feasible; however, compliance to supplements and the rigorous study assessments was high. Solutions to address recruitment, such as more liberal eligibility criteria, need to be considered in the design of a large-scale RCT before it can be carried out in this challenging population. Funding Sources Helen McCall Hutchison Award and Réseau québécois de la recherche sur le vieillissement of FRQS.

Effect of 4000 IU Vitamin D3 Supplements on Advanced Glycation End Products (AGEs) Among Adults with Type 2 Diabetes and Hypovitaminosis D

Abstract Objectives Diabetes related complications include kidney, eye, heart diseases and amputations. Advanced Glycation End Products, (AGEs) are biomarkers of T2D. AGEs are covalent adducts formed from reactions between sugars and proteins or lipids. Vitamin D deficiency, prevalent with T2D, increases oxidative stress and inflammation that promotes the formation of AGEs. This study assessed the effect of 4000 IU vitamin D supplements on AGEs in adults with T2D and vitamin D deficiency/insufficiency. Methods We assessed changes in serum AGEs of 41 African Americans and Hispanics with T2D and hypovitaminosis D who were supplemented with 4000 IU of vitamin D3 for 6 months. Total AGEs were assessed using commercially available kits (Biotang Inc/TSZ Elisa, Waltham, MA, USA). Results The mean age of study participants was 54 ± 8 years. AGEs significantly increased at 3 months compared to baseline (Mean Difference = −13.70 ng/ml, P = 0.007). The mean level of AGEs decreased significantly at 6 months of supplementation (Mean Difference = 9.79 ng/ml, P = 0.020). Additionally, the mean serum levels of AGEs were significantly higher at 3 months compared to 6 months among study participants (Mean Difference = 24.52 ng/ml, P < 0.0001). Conclusions Daily supplementation of 4000 IU vitamin D3 reduced AGEs at 6 months but not at 3 months. Supplementation of this minority population with vitamin D may delay the accumulation of AGEs and complications related to T2D. Funding Sources Funding for this research was provided through an NIH/NIDDK sponsored grant.

Commentary: Myths and facts on vitamin D amidst the COVID-19 pandemic

Commentary: Myths and facts on vitamin D amidst the COVID-19 pandemic

The impact of vitamin D3 intake on inflammatory markers in multiple sclerosis patients and their first-degree relatives.

Background & aimsIn our previous study, a Seesaw model was proposed for the fluctuation of crucial anti- (IL-10) and pro-inflammatory (Il-6 & IL-17A) cytokines through vitamin D3. In this paper, however, it is intended to extend the mentioned model by assessing the expression mRNA levels of IL-27 and TGF-β1 as well as the changes of plasma levels of IL-27, TGF-β1, IL-17A, IL-10, and IL-6 after treatment by vitamin D3.MethodVenous blood samples were drawn from Healthy Participants (HP, n = 25) and First-Degree Relative Participants (FDRP, n = 25) as control groups and Multiple Sclerosis Participants (MSP, n = 25) before and after eight weeks of supplementation with 50000 IU vitamin D3. The mRNA expression and plasma concentrations were gauged by using Real-Time PCR and ELISA assay, respectively.ResultsThe mRNA surfaces of IL-27, as well as TGF-β1, were up-regulated. However, the plasma levels of TGF-β1, IL-17A, and IL-6 were significantly different among the three groups. In addition, the plasma levels of IL-27, TGF-β1, IL-10, IL-17A, and IL-6 significantly changed following the administration of vitamin D3.ConclusionThe findings of this paper illustrate that anti-inflammatory cytokines could have a key role in immunomodulatory functions due to their anti-inflammatory functions. To conclude, this might contribute to preventing the pathophysiological process of MS. Also, the proposed model could be used as a preventive way on disposed people to multiple sclerosis, particularly in first degree relatives of these patients.

Single High-dose Vitamin D3 Supplementation in Pediatric Patients With Inflammatory Bowel Disease and Hypovitaminosis D.

The primary aim was to determine the effectiveness of a single high-dose of oral vitamin D3 (stoss therapy) in children with inflammatory bowel disease (IBD) and hypovitaminosis D. Our secondary aim was to examine the safety of stoss therapy. We conducted a randomized, prospective study of 44 patients, ages 6 to 21 years, with IBD and 25-hydroxyvitamin D (25-OHD) concentrations <30 ng/mL. Patients were randomized to receive 50,000 IU of vitamin D3 once weekly for 6 weeks (standard of care, SOC group) or 300,000 IU once (stoss group). Serum 25-OHD levels were obtained at baseline, 4 and 12 weeks. Safety monitoring labs were performed at week 4. Thirty-nine of 44 enrolled patients (19 stoss, 20 SOC) completed the study. Baseline vitamin D levels were not significantly different between the groups. Stoss therapy resulted in a substantial rise in 25-OHD levels at week 4, equivalent to the weekly regimen (53.6 ± 17.3 vs 54.6 ± 17.5 ng/mL). At week 12, serum 25-OHD levels decreased in both groups, significantly lower in the stoss group, but remained close to 30 ng/mL (29.8 ± 7.1 vs 40.4 ± 11.9 ng/mL, P = 0.04). A significant interaction with treatment group over time was observed (P = 0.0003). At the week-4 time point, all patients who received stoss therapy had normal serum calcium and PTH levels. Eighty percentage of patients preferred stoss therapy to the weekly regimen. Stoss therapy was safe and effective in raising 25-OHD in children with IBD commensurate to that of the weekly regimen.

Effects of a vitamin and mineral bolus on beef heifer feedlot performance, feeding behavior, carcass characteristics, and liver mineral concentrations.

Crossbred beef heifers (n = 23; initial body weight [BW] = 370 ± 12 kg) housed at the North Dakota State University Beef Cattle Research Complex in Fargo, ND, were used to evaluate the effects of a 250-d slow-release vitamin and mineral bolus on feedlot performance, feeding behavior, carcass characteristics, and liver mineral concentrations. Heifers were assigned to one of two treatments: 1) received no supplemental mineral or vitamin (CON, n = 12) or 2) received two boluses on day 0 (minimum of 3,740 mg Ca, 16,456 mg Mg, 112 mg Na, 11,220 mg Cu, 2,995 mg I, 2,805 mg Mn, 505 mg Se, 48,620 mg Zn, 468 mg Co, 824,296 IU vitamin A, 173,102 IU vitamin D3, and 4,121 IU vitamin E bases on company analysis; Reloader 250 Mineral Bolus, Cargill Inc., Minneapolis, MN; MIN, n = 11). Heifers were fed a total mixed ration containing corn silage, grass hay, dried distillers grains with solubles, and dry-rolled corn (16.05% crude protein, 1.44 Mcal/kg NEg) with no added vitamin or mineral supplement. Feed intake and number and time of visits were recorded for each heifer using the Insentec feeding system (Hokofarm Group B.V., the Netherlands) during the feeding period. Liver biopsies were collected from heifers on days 0, 69, and 134 of the feeding period for analysis of mineral concentrations and analyzed as repeated measures. Heifers were slaughtered after 150 or 169 d on feed, and carcass characteristics were determined. Final BW, average daily gain, dry matter index, gain:feed, and carcass characteristics were not influenced (P > 0.19) by treatment. Control heifers visited feeders more but spent less time per visit and ate less per visit compared with MIN heifers (P < 0.03). No differences (P > 0.06) in liver mineral concentrations were observed between treatments, and concentrations of Se, Cu, Mo, Mn, and Co decreased (P < 0.05) over the feeding period. In this experiment, the slow-release vitamin and mineral bolus evaluated failed to increase liver mineral concentrations during the finishing period or influence heifer performance and carcass characteristics.

Vitamin D3 Supplementation in Diarrhea-Predominant Irritable Bowel Syndrome Patients: The Effects on Symptoms Improvement, Serum Corticotropin-Releasing Hormone, and Interleukin-6 – A Randomized Clinical Trial

Objectives: This study aimed to evaluate whether vitamin D deficiency is associated with the severity of symptoms of irritable bowel syndrome (IBS) patients. Stress and gut inflammation can increase the serum level of corticotropin-releasing hormone (CRH) and interleukin-6 (IL-6), leading to a change in bowel movements. The aim of this study was to evaluate the anti-inflammatory and psychological effects of vitamin D3 supplementation on the symptom improvement of patients with a diarrhea-predominant form of IBS (IBS-D). Methods: Eighty-eight IBS-D patients (age: 18–65 years) based on Rome IV criteria who suffered from vitamin D deficiency and/or insufficiency were enrolled in this randomized, placebo-controlled trial from February 2017 to May 2018 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were randomly divided into two groups. The intervention group received 50,000 IU vitamin D3 weekly and the control group received a placebo for 9 weeks. All patients received Mebeverine 135 mg twice a day besides supplementation. The IBS Severity Score System (IBS-SSS), serum 25(OH) vitamin D3, CRH, and IL-6 were measured before and after interventions. Results: Seventy-four patients completed the study. The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH. Also, in the treatment group, IBS-SSS and IL-6 were significantly reduced at the end of the study from baseline (p < 0.01 and p < 0.03, respectively). Conclusion: Our findings indicate that vitamin D3 supplementation can modulate the serum level of CRH and IL-6 and can improve symptoms in IBS-D patients. Vitamin D3 supplementation should be considered in IBS-D patients who suffer from vitamin D deficiency and/or insufficiency.

A promising wound dressing based on alginate hydrogels containing vitamin D3 cross-linked by calcium carbonate/d-glucono-δ-lactone.

In the present study, we fabricated vitamin D3-loaded alginate hydrogel and assessed its wound healing capability in the animal model. The various concentrations of vitamin D3 were added to the pre-dissolved sodium alginate in deionized water and cross-linked by calcium carbonate in combination with d-glucono-δ-lactone. The microstructure, swelling behavior, weight loss, hemo- and cytocompatibility of the fabricated hydrogels were evaluated. In the last stage, the therapeutic efficacy of the prepared hydrogels was evaluated in the full-thickness dermal wound model. The scanning electron microscopy images showed that the prepared hydrogel was highly porous with the porosity of 89.2 ± 12.5% and contained the interconnected pores. Weight loss assessment showed that the prepared hydrogel is biodegradable with the weight loss percentage of about 89% in 14days. The results showed that the prepared hydrogels were hemo- and cytocompatible. The animal study results implied that alginate hydrogel/3000IU vitamin D3 group exhibited the highest wound closure present which was statistically significant than the control group (p < 0.05). Moreover, the histological examinations revealed that hydrogel containing 3000IU vitamin D3 had the best performance and induced the highest re-epithelialization and granular tissue formation. All in all, this study suggests that alginate hydrogels with 3000IU vitamin D3 can be exploited as a potential wound dressing in skin tissue engineering.

Effects of Maternal Vitamin D3 Supplementation on Offspring Epigenetic Clock of Gestational Age at Birth: A Post-hoc Analysis of a Randomized Controlled Trial

ABSTRACT Vitamin D could be beneficial for healthy ageing in humans. We previously found that vitamin D supplementation may slow down epigenetic ageing in young African American adults. We tested new epigenetic clocks developed for neonates among a multiethnic population, and tested the hypothesis that maternal vitamin D supplementation would slow down the epigenetic gestational age acceleration (GAA) in newborn babies. Ninety-two pregnant women (aged 29.6 ± 4.8 y; 21% African Americans, 28% Hispanics) were randomized to receive 4000 IU/day vitamin D3 or placebo, plus prenatal vitamins containing 400 IU vitamin D3 during pregnancy in a randomized controlled trial (RCT). Cord blood genome-wide methylation analysis was performed on the Illumina Infinium MethylationEPIC Beadchip. DNA methylation gestational age was calculated based on two calculations developed by Knight and Bohlin. DNA methylation gestational ages calculated by Knight’s clock and Bohlin’ clock were highly correlated with the gestational age in the placebo group (correlation coefficients = 0.88, p s< 0.001, respectively). GAA was associated with higher birth weight (p = 0.039). In the entire cohort, vitamin D3 supplementation was not associated with GAA (p > 0.05). However, vitamin D3 supplementation decreased GAA by both Knight’s clock (β = −0.89, p = 0.047) and Bohlin’s clock (β = −0.71, p = 0.005) in the African American participants. Maternal vitamin D3 supplementation may slow down the epigenetic gestational ageing process in African American neonates. Long-term follow-up studies are warranted to determine the role of epigenetic age acceleration in the growth and development of offspring.

Genetic Components of 25-Hydroxyvitamin D Increase in Three Randomized Controlled Trials.

The 25-Hydroxyvitamin D (25[OH)D) serum concentration depends on vitamin D intake, endogenous vitamin D production and genetic factors. The latter have been demonstrated in large genome-wide association studies indicating that single nucleotide polymorphisms (SNPs) in genes related to the vitamin D metabolism are as important for serum 25(OH)D levels as the influence of season. The mechanism on how these SNPs influence serum 25(OH)D levels are still unclear. The aim of the present study was to investigate the genetic effects of ten selected SNPs related to vitamin D metabolism on 25-hydroxyvitamin D increase (∆25(OH)D) after vitamin D supplementation in three randomized controlled trials. Genotypes of SNPs related to vitamin D metabolism were determined in 411 participants with 25(OH)D concentrations < 75 nmol/l receiving 20,000 IU cholecalciferol per week for 8 or 12 weeks after study inclusion. For the vitamin D receptor (VDR) rs10783219 polymorphism, the minor A-allele was associated with lower ∆25(OH)D values in the entire study population (p = 0.022), which was not consistent in all three cohorts when analysed separately. VDR rs10783219 might therefore be a genetic modulator of increasing 25-hydroxyvitamin D concentrations. Considering the wide-spread use of vitamin D supplementation, future large and well-designed randomized controlled trials (RCTs) should investigate the clinical impact of this polymorphism.

Postural Balance Effects Associated with 400, 4000 or 10,000 IU Vitamin D3 Daily for Three Years: A Secondary Analysis of a Randomized Clinical Trial.

Vitamin D supplementation is proposed as a fall prevention strategy, as it may improve neuromuscular function. We examined whether three years of vitamin D supplementation (400, 4000 or 10,000 IU daily) affects postural sway in older adults. Three hundred and seventy-three non-osteoporotic, vitamin D-sufficient, community-dwelling healthy adults, aged 55–70 years, were randomized to 400 (n = 124), 4000 (n = 125) or 10,000 (n = 124) IU daily vitamin D3 for three years. Sway index was assessed at baseline, 12-, 24- and 36-months using the Biosway machine. We tested participants under four conditions: eyes open or eyes closed with firm (EOFI, ECFI) or foam (EOFO, ECFO) surfaces. Secondary assessments examined sway in the anterior-posterior (AP) and medio-lateral (ML) directions. Linear mixed effects models compared sway between supplementation groups across time. Postural sway under EOFO and ECFO conditions significantly improved in all supplementation groups over time. Postural sway did not differ between supplementation groups at any time under any testing conditions in normal, AP or ML directions (p > 0.05 for all). Our findings suggest that high dose (4000 or 10,000 IU) vitamin D supplementation neither benefit nor impair balance compared with 400 IU daily in non-osteoporotic, vitamin D-sufficient, healthy older adults.

No Association Between Vitamin D Supplementation and Risk of Colorectal Adenomas or Serrated Polyps in a Randomized Trial

The effects of vitamin D on risk of colorectal cancer precursors are not clear. We examined the influence of vitamin D supplementation on risk of colorectal adenomas and serrated polyps in a prespecified ancillary study of a large-scale prevention trial (the vitamin D and omegA-3 trial, VITAL) of individuals who were free of cancer and cardiovascular disease at enrollment. In VITAL trial, 25,871 adults with no history of cancer or cardiovascular disease (12,786 men 50 years or older and 13,085 women 55 years or older) were randomly assigned to groups given daily dietary supplements (2000 IU vitamin D3 and 1 g marine n-3 fatty acid) or placebo. Patients were assigned to groups from November 2011 through March 2014 and the study ended on December 31, 2017. We confirmed conventional adenomas and serrated polyps by reviewing histopathology reports from participants who had reported a diagnosis of polyps and were asked by their doctors to return for a repeat colonoscopy or sigmoidoscopy in 5 years or less. We calculated the odds ratios (ORs) and 95% CIs by logistic regression, after adjusting for age, sex, n-3 treatment assignment, and history of endoscopy at time of randomization. During a median follow-up of 5.3 years, we documented 308 cases of conventional adenomas in 12,927 participants in the vitamin D group and 287 cases in 12,944 participants in the placebo group (OR for the association of vitamin D supplementation with adenoma, 1.08; 95% CI, 0.92-1.27). There were 172 cases of serrated polyps in the vitamin D group and 169 cases in the placebo group (OR for the association of vitamin D supplementation with serrated polyp, 1.02; 95% CI, 0.82-1.26). Supplementation was not associated with polyp size, location, multiplicity, or histologic features. We found evidence for an interaction between vitamin D supplementation and serum level of 25-hydroxyvitamin D, measured in 15,787 participants at randomization. Among individuals with serum levels of 25-hydroxyvitamin D below 30 ng/mL, the OR associated with supplementation for conventional adenoma was 0.82 (95% CI, 0.60-1.13), whereas among individuals with serum levels of 25-hydroxyvitamin D above 30 ng/mL, the OR for conventional adenoma was 1.20 (95% CI, 0.92-1.55) (P for interaction= .07). There was a significant interaction between vitamin D supplementation and serum level of 25-hydroxyvitamin D in their association with advanced adenoma (P for interaction= .04). Based on an ancillary study of data from the VITAL trial, daily vitamin D supplementation (2000 IU) was not associated with risk of colorectal cancer precursors in average-risk adults not selected for vitamin D insufficiency. A potential benefit for individuals with low baseline level of vitamin D requires further investigation. ClinicalTrials.gov number: NCT01169259.

Effect of Vitamin D Injection in Recurrent Benign Paroxysmal Positional Vertigo with Vitamin D Deficiency.

Introduction There have been reports indicating that patients with frequently recurring benign paroxysmal positional vertigo (BPPV) had vitamin D deficiency, and some studies indicated that the treatment of severe vitamin D deficiency is effective in the reduction of the recurrence of BPPV. Objective The purpose of the present study was to examine the effects of Vitamin D 3 injection on recurrence among patients with a 10 ng/mL or lower 25-hydroxyvitamin D blood concentration diagnosed with BPPV. Methods Among 99 patients with idiopathic BPPV with vitamin D deficiency, 25 patients (case group) were submitted to 3 to 4 injections of 200,000 IU of vitamin D 3 in the first year. In total, 50 patients in the control group were selected through frequency matching, with 25 patients in the case group. Age, gender, and type of BPPV are used in matching variables with 1:2 matched data. The subjects of the study group were followed up for 24 months. Results The differences in relapse rates between the case and the control groups were examined using the non-parametric Kruskal-Wallis test for k independent samples. With regard to the relapse rates of the entire case and control groups by period, from 0 to 6 months ( p < 0.531), from 7 to 12 months ( p < 1.000), and from 13 to 24 months ( p < 0.711), and in the entire study period ( p < 0.883) there were no statistically significant differences. Conclusion The present case-control study indicated that vitamin D 3 injection had no significant effect on the recurrence of BPPV patients with vitamin D deficiency when age, gender, and type of BPPV were homogeneous between the two groups.

Effects of Seasonal Vitamin D3 Supplementation on Strength, Power, and Body Composition in College Swimmers.

The purpose of this study was to evaluate the impact of fall season vitamin D3 supplementation on strength/power, body composition, and anabolic hormones in swimmers with optimal vitamin D status at summer's end. Male and female National Collegiate Athletic Association Division I swimmers (N = 19) with optimal 25-hydroxyvitamin D [25(OH)D] randomly received 5,000IU of vitamin D3 (VITD) or placebo (PLA) daily for 12 weeks while participating in swimming and strength and conditioning training (August-November). Before and after the intervention, the participants underwent blood sampling for analysis of serum 25(OH)D, parathyroid hormone, total testosterone, free testosterone, sex hormone-binding globulin, and insulin-like growth factor 1, dual-energy X-ray absorptiometry, and strength/power testing (bench press, squat, dead lift, standing broad jump, vertical jump, and dips and pull-ups). Sex was used as a covariate for analyses. The 25(OH)D was decreased by 44% in PLA (p < .05) and increased by 8% in VITD over the 12 weeks. Fat-free mass increased in VITD (56.4-59.1kg; p < .05), but not PLA (59.4-59.7kg; p < .01). Significant Group × Time interaction effects were observed for dead lift (F = 21.577, p < .01) and vertical jump (F = 11.219, p < .01), but no other strength/power tests. Total testosterone decreased similarly in both groups, but free testosterone decreased and sex hormone-binding globulin increased only in PLA (p < .01). There were no group differences or changes in insulin-like growth factor 1 with the intervention. The findings suggest that vitamin D supplementation is an efficacious strategy to maintain 25(OH)D during the fall season training and to enhance some aspects of strength/power and fat-free mass in swimmers. Further research on the relationship between vitamin D and anabolic hormones is needed.

High-dose oral vitamin D supplementation and mortality in people aged 65-84 years: the VIDAL cluster feasibility RCT of open versus double-blind individual randomisation.

Randomised controlled trials demonstrating improved longevity are needed to justify high-dose vitamin D supplementation for older populations. To demonstrate the feasibility of a large trial (n ≈ 20,000) of high-dose vitamin D in people aged 65-84 years through general practitioner (GP) practices, and to cluster randomise participating practices between open-label and double-blind randomisation to compare effects on recruitment, compliance and contamination. Twenty GP practices were randomised in matched pairs between open-label and double-blind allocation. Within each practice, patients were individually randomised to vitamin D or control (i.e. no treatment or placebo). Participants were invited to attend their GP practice to provide a blood sample and complete a lifestyle questionnaire at recruitment and again at 2 years. Randomisation by telephone followed receipt of a serum corrected calcium assay confirming eligibility (< 2.65 nmol/l). Treatment compliance was reported by quarterly follow-up forms sent and returned by e-mail or post (participant choice). GP visits and infections were abstracted from GP records. Hospital attendances, cancer diagnoses and deaths were ascertained by linkage to Hospital Episode Statistics and national registration through NHS Digital. GP practices in England. Recruitment opened in October 2013 and closed in January 2015. A total of 1615 registered patients aged 65-84 years were randomised: 407 to vitamin D and 421 to no treatment in open practices; 395 to vitamin D and 392 to placebo in blind practices. There was a 24-month treatment period: 12 monthly doses (100,000 IU of vitamin D3 or placebo as 5 ml oily solution) were posted after randomisation and at 1 year (100,000 IU per month corresponds to 3300 IU per day). Reminders were sent monthly by e-mail, text message or post. Recruitment, compliance, contamination and change in circulating 25-hydroxyvitamin D [25(OH)D] from baseline to 2 years. Participation rates (randomised/invited) were 15.0% in open practices and 13.4% in double-blind practices (p = 0.7). The proportion still taking study medication at 2 years was 91.2% in open practices and 89.2% in double-blind practices (p = 0.4). The proportion of control participants taking > 400 IU vitamin D per day at 2 years was 5.0% in open practices and 4.8% in double-blind practices. Mean serum 25(OH)D concentration was 51.5 nmol/l [95% confidence interval (CI) 50.2 to 52.8 nmol/l] with 82.6% of participants < 75 nmol/l at baseline. At 2 years, this increased to 109.6 nmol/l (95% CI 107.1 to 112.1 nmol/l) with 12.0% < 75 nmol/l in those allocated to vitamin D and was unaltered at 51.8 nmol/l (95% CI 49.8 to 53.8 nmol/l) in those allocated to no vitamin D (no treatment or placebo). A trial could recruit 20,000 participants aged 65-84 years through 200 GP practices over 2 years. Approximately 80% would be expected to adhere to allocated treatment (vitamin D or placebo) for 5 years. The trial could be conducted entirely by e-mail in participants aged < 80 years, but some participants aged 80-84 years would require postal follow-up. Recruitment and treatment compliance would be similar and contamination (self-administration of vitamin D) would be minimal, whether control participants are randomised openly to no treatment with no contact during the trial or randomised double-blind to placebo with monthly reminders. Current Controlled Trials ISRCTN46328341 and EudraCT database 2011-003699-34. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 10. See the NIHR Journals Library website for further project information.

Efficacy of Vitamin D for the Prevention of Pulmonary Tuberculosis and Mortality in HIV: A Randomised, Double-Blind, Placebo-Controlled Trial

Background: Observational data suggests that low vitamin D status is associated with an increased incidence of pulmonary tuberculosis (TB) and mortality among people living with HIV; however, the efficacy of vitamin D supplementation remains unknown. Methods: We conducted a randomized, double-blind, placebo-controlled trial of vitamin D3 supplementation among 4,000 HIV-infected adults initiating antiretroviral therapy (ART) with low 25-hydroxyvitamin D (25(OH)D) levels in Dar es Salaam, Tanzania. The vitamin D group received weekly 50,000 IU vitamin D3 supplements for the first month of ART followed by daily 2,000 IU vitamin D3 supplements. The placebo arm received a matching weekly and daily placebo regimen. Findings: A total of 415 deaths were recorded and there was no overall effect of vitamin D3 supplementation on the risk of mortality (hazard ratio (HR): 1·04; 95% CI: 0·85-1·25; p=0·73). However, vitamin D3 supplementation appeared to reduce the risk of death by 41% (0-65%) among participants with baseline pulmonary TB and by 48% (95% CI: 11-69%) among those with WHO HIV Stage IV disease at the time of ART initiation. There was no effect on the overall incidence of pulmonary TB (HR: 0·78; 95% CI: 0·54-1·13; p=0·19), although vitamin D3 was found to reduce the incidence of sputum smear-positive pulmonary TB (HR: 0·54; 95% CI: 0·31-0·92; p=0·03). The vitamin D3 regimen increased serum 25(OH)D (p<0·001) and did not increase the risk of hypercalcemia (p=1·00) as compared to placebo. Interpretation: Vitamin D3 supplementation may improve survival for the subset HIV-infected adults initiating ART with pulmonary TB disease or advanced HIV disease and reduce the incidence of sputum smear positive pulmonary TB. Trial Registration: ClinicalTrials.gov, NCT01798680. Funding Statement: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Declaration of Interests: The authors stated: None to declare. Ethics Approval Statement: The trial protocol was approved by the Harvard T. H. Chan School of Public Health Institutional Review Board, the Tanzanian National Health Research Ethics Sub Committee (NatHREC), and the Tanzania Food and Drug Authority (TFDA) and was overseen by an independent data and safety monitoring board.

The effect of vitamin D and calcium supplementation on inflammatory biomarkers, estradiol levels and severity of symptoms in women with postpartum depression: a randomized double-blind clinical trial

ABSTRACT Objectives: Postpartum depression (PPD) is a major depressive disorder. Vitamin D deficiency may play a role in PPD pathogenesis. This study was designed to determine the effect of vitamin D and calcium supplementation on the severity of symptoms and some related inflammatory biomarkers in women with PPD. Materials and Methods: Eighty-one women with a PPD score >12 participated in this study. A total of 27 patients were randomly assigned into three groups (1:1:1 ratio) to receive either 50,000 IU vitamin D3 fortnightly + 500 mg calcium carbonate daily; or 50,000 IU vitamin D3 fortnightly + placebo of calcium carbonate daily, or placebo of vitamin D3 fortnightly + placebo of calcium carbonate daily (placebo group) for 8 weeks. At the baseline and end of the study, the severity score of PPD, levels of 25-hydroxy vitamin D, calcium, tumor necrosis factor-alpha (TNFα), interleukin 6 (IL6) and estradiol were measured. Results: The PPD score had more reduction in the vitamin D + calcium and vitamin D + calcium placebo groups than that of the placebo group (−1.7 ± 3.44, −4.16 ± 5.90 and 0.25 ± 2.81, respectively; p = 0.008). The effect of vitamin D on the PPD score was larger when vitamin D was given alone than given together with calcium (p = 0.042 and p = 0.004, respectively). No significant differences in estradiol, IL6 and TNFα were observed between the three groups. Discussion: Vitamin D may be effective in improving the clinical symptoms of PPD; however, the mechanism of the effect might not entirely operate through inflammatory and/or hormonal changes.

Use of Vitamin D With Anti-Tumor Necrosis Factor Therapy for Crohn's Disease.

BackgroundVitamin D (VD) has an important role in regulating gut mucosal immunity, and seems to be inversely linked to disease activity and more frequent relapses in inflammatory bowel disease. In this study, we evaluated patients with Crohn’s disease (CD) treated with anti-tumor necrosis factor (TNF) in association with VD.MethodsA double-blind, randomized, prospective study was conducted. Thirty patients with a history of moderate to severe CD, in use of anti-TNF, of both sexes, 18 to 70 years, with the dosage of VD < 75 nmol/L (30 ng/mL) were randomized and divided into three groups: group 1 (G1): 10 patients received 2,000 IU VD, per os (PO)/week for 8 weeks; group 2 (G2): 10 patients received 10,000 IU VD, PO/week for 8 weeks; group 3 (G3): 10 patients received 50,000 IU VD, PO/week for 8 weeks. Before and at the end of 8 weeks patients were submitted to VD, fecal calprotectin (FC) and C-reactive protein (CRP) dosage. Follow-up period was 52 weeks, and they are checked for disease activity recurrence (Crohn’s disease activity index (CDAI) > 150, FC > 300 and computerized tomography (CT) scan), FC, CRP, and VD levels.ResultsIncreased VD levels were observed in all groups (P < 0.0001). CRP did not change. There was a significant decrease of FC in G3 (1,014 ± 850 vs. 483 ± 564; P = 0.04), no significant decrease in G2 (76,767 ± 751 vs. 535 ± 823; P = 0.2) and increase in G1 (1,101 ± 744 vs. 1,357 ± 819; P = 0.4). During the 52-week follow-up period, it was showed that recurrent disease activity (CDAI > 150, FC > 200 and CT scan) was predominant in patients with VD < 30 group, and the remission rate was predominant in patients with VD > 30 group (P = 0.0001). A statistically significant difference in VD levels was noted in CD patients after 52 weeks that presented flare or disease remission (P = 0.001).ConclusionsUse of VD associated with anti-TNF treatment may improve clinical response in CD. VD levels greater than 30 ng/mL have better rates of remission.