DO IT Trial: vitamin D Outcomes and Interventions in Toddlers - a TARGet Kids! randomized controlled trial.

BackgroundVitamin D levels are alarmingly low (<75 nmol/L) in 65-70% of North American children older than 1 year. An increased risk of viral upper respiratory tract infections (URTI), asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations, two of the most common and costly illnesses of early childhood. The objectives of this study are: 1) to compare the effect of 'high dose' (2000 IU/day) vs. 'standard dose' (400 IU/day) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children; and 2) to assess the effect of 'high dose' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI.Methods/designThis study is a pragmatic randomized controlled trial. Over 4 successive winters we will recruit 750 healthy children 1-5 years of age. Participating physicians are part of a primary healthcare research network called TARGet Kids!. Children will be randomized to the 'standard dose' or 'high dose' oral supplemental vitamin D for a minimum of 4 months (200 children per group). Parents will obtain a nasal swab from their child with each URTI, report the number of asthma exacerbations and complete symptom checklists. Unscheduled physician visits for URTIs and asthma exacerbations will be recorded. By May, a blood sample will be drawn to determine vitamin D serum levels. The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model. Secondary analyses will compare vitamin D serum levels, asthma exacerbations and the frequency of specific viral agents between groups.DiscussionIdentifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs. This information will assist in determining practice and health policy recommendations related to vitamin D supplementation in healthy Canadian preschoolers

Comparing the effects of sun exposure and vitamin D supplementation on vitamin D insufficiency, and immune and cardio-metabolic function: the Sun Exposure and Vitamin D Supplementation (SEDS) Study

BACKGROUND Adults living in the sunny Australian climate are at high risk of skin cancer, but vitamin D deficiency (defined here as a serum 25-hydroxyvitamin D (25(OH)D) concentration of less than 50 nmol/L) is also common. Vitamin D deficiency may be a risk factor for a range of diseases. However, the optimal strategies to achieve and maintain vitamin D adequacy (sun exposure, vitamin D supplementation or both), and whether sun exposure itself has benefits over and above initiating synthesis of vitamin D, remain unclear. The Sun Exposure and Vitamin D Supplementation (SEDS) Study aims to compare the effectiveness of sun exposure and vitamin D supplementation for the management of vitamin D insufficiency, and to test whether these management strategies differentially affect markers of immune and cardio-metabolic function. METHODS/DESIGN The SEDS Study is a multi-centre, randomised controlled trial of two different daily doses of vitamin D supplementation, and placebo, in conjunction with guidance on two different patterns of sun exposure. Participants recruited from across Australia are aged 18-64 years and have a recent vitamin D test result showing a serum 25(OH)D level of 40-60 nmol/L. DISCUSSION This paper discusses the rationale behind the study design, and considers the challenges but necessity of data collection within a non-institutionalised adult population, in order to address the study aims. We also discuss the challenges of participant recruitment and retention, ongoing engagement of referring medical practitioners and address issues of compliance and participant retention. TRIAL REGISTRATION Australia New Zealand Clinical Trials Registry: ACTRN12613000290796 Registered 14 March 2013

Vitamin D Supplementation for Depressive Symptoms: A Systematic Review and Meta-analysis of Randomized Controlled Trials

OBJECTIVE: The aim of this study was to review the effects of vitamin D supplementation on depressive symptoms in randomized controlled trials. Although low vitamin D levels have been observationally associated with depressive symptoms, the effect of vitamin D supplementation as an antidepressant remains uncertain. METHODS: MEDLINE, CINAHL, AMED, PsycINFO, Scopus, The Cochrane Library, and references of included reports (through May 2013) were searched. Two independent reviewers identified and extracted data from randomized trials that compared the effect of vitamin D supplementation on depressive symptoms to a control condition. Two additional reviewers assessed study quality using The Cochrane Risk of Bias Tool. Seven trials (3191 participants) were included. RESULTS: Vitamin D supplementation had no overall effect on depressive symptoms (standardized mean difference [SMD], 0.14; 95% confidence interval [CI], -0.33 to 0.05, p = .16), although considerable heterogeneity was observed. Subgroup analysis showed that vitamin D supplementation for participants with clinically significant depressive symptoms or depressive disorder had a moderate, statistically significant effect (2 studies: SMD, -0.60; 95% CI, -1.19 to -0.01; p = .046), but a small, nonsignificant effect for those without clinically significant depression (5 studies: SMD, -0.04; 95% CI, -0.20 to 0.12; p = .61). Most trials had unclear or high risk of bias. Studies varied in the amount, frequency, duration, and mode of delivery of vitamin D supplementation. CONCLUSIONS: Vitamin D supplementation may be effective for reducing depressive symptoms in patients with clinically significant depression; however, further high-quality research is needed

Does vitamin D supplementation alter plasma adipokines concentrations? A systematic review and meta-analysis of randomized controlled trials

We aimed to elucidate the role of vitamin D supplementation on adipokines through a systematic review and a meta-analysis of randomized placebo-controlled trials (RCTs). The search included PUBMED, Scopus, Web of Science and Google Scholar through July 1st, 2015. Finally we identified 9 RCTs and 484 participants. Meta-analysis of data from 7 studies did not find a significant change in plasma adiponectin concentrations following vitamin D supplementation (mean difference [MD]: 4.45%, 95%CI: −3.04, 11.93, p = 0.244; Q = 2.18, I2 = 0%). In meta-regression, changes in plasma adiponectin concentrations following vitamin D supplementation were found to be independent of treatment duration (slope: 0.25; 95%CI: −0.69, 1.19; p = 0.603) and changes in serum 25-hydroxy vitamin D [25(OH)D] levels (slope: −0.02; 95%CI: −0.15, 0.12; p = 0.780). Meta-analysis of data from 6 studies did not find a significant change in plasma leptin concentrations following vitamin D supplementation (MD: −4.51%, 95%CI: −25.13, 16.11, p = 0.668; Q = 6.41, I2 = 21.97%). Sensitivity analysis showed that this effect size is sensitive to one of the studies; removing it resulted in a significant reduction in plasma leptin levels (MD: −12.81%, 95%CI: −24.33, −1.30, p = 0.029). In meta-regression, changes in plasma leptin concentrations following vitamin D supplementation were found to be independent of treatment duration (slope: −1.93; 95%CI: −4.08, 0.23; p = 0.080). However, changes in serum 25(OH)D were found to be significantly associated with changes in plasma leptin levels following vitamin D supplementation (slope: 1.05; 95%CI: 0.08, 2.02; p = 0.033). In conclusion, current data did not indicate a significant effect of vitamin D supplementation on adiponectin and leptin levels

Association between Vitamin D and Heart Failure Mortality in 10,974 Hospitalized Individuals

A broad range of chronic conditions, including heart failure (HF), have been associated with vitamin D deficiency. Existing clinical trials involving vitamin D supplementation in chronic HF patients have been inconclusive. We sought to evaluate the outcomes of patients with vitamin D supplementation, compared with a matched cohort using real-world big data of HF hospitalization. This study was based on the Diagnosis Procedure Combination database in the Japanese Registry of All Cardiac and Vascular Datasets (JROAD-DPC). After exclusion criteria, we identified 93,692 patients who were first hospitalized with HF between April 2012 and March 2017 (mean age was 79 ± 12 years, and 52.2% were male). Propensity score (PS) was estimated with logistic regression model, with vitamin D supplementation as the dependent variable and clinically relevant covariates. On PS-matched analysis with 10,974 patients, patients with vitamin D supplementation had lower total in-hospital mortality (6.5 vs. 9.4%, odds ratio: 0.67, p < 0.001) and in-hospital mortality within 7 days and 30 days (0.9 vs. 2.5%, OR, 0.34, and 3.8 vs. 6.5%, OR: 0.56, both p < 0.001). In the sub-group analysis, mortalities in patients with age < 75, diabetes, dyslipidemia, atrial arrhythmia, cancer, renin-angiotensin system blocker, and β-blocker were not affected by vitamin D supplementation. Patients with vitamin D supplementation had a lower in-hospital mortality for HF than patients without vitamin D supplementation in the propensity matched cohort. The identification of specific clinical characteristics in patients benefitting from vitamin D may be useful for determining targets of future randomized control trials

The Observational Investigation of Vitamin D and the Effect on Hypertension (OIVEH) Study

Background It is uncertain if vitamin D supplementation improves cardiovascular health, more specifically, the systolic and diastolic blood pressures, and the data from previous trials investigating supplementation and the effects on the blood pressure are limited. Methods The following scholarly project was a retrospective observational study, examining randomly selected participants with chronic kidney disease and hypertension from a local nephrology practice. The Student’s t-test, Pearson’s r correlation, and ANOVA statistical tests were utilized to determine if vitamin D supplementation improved the systolic and diastolic blood pressures. Results A total of 260 participants were examined. The mean systolic blood pressure of patients using vitamin D supplementation (M = 139.72, SD = 21.69, N = 125) was not significantly different from those without vitamin D supplementation (M 136.67, SD 21.62, N= 135) t(258) = -1.136, p = 0.752). The mean diastolic blood pressure of patients using vitamin D supplementation (M = 82.90, SD 12.28, N = 125) was not significantly different from those without vitamin D supplementation (M = 82.91, SD 11.22, N = 135) t(258) = -2.84, p = 0.565). Conclusion In this retrospective observational study, supplementation with vitamin D did not result in a statistically significant reduction in the systolic or diastolic blood pressures when compared to those who did not take a vitamin D supplement. Future research, which may benefit from considering the confounding variables identified in this study, may provide the needed data to determine if vitamin D supplementation could improve the systolic and diastolic blood pressures in those with CKD. KEY WORDS: cholecalciferol, ergocalciferol, vitamin D3, vitamin D2, 25-hydroxyvitamin D3, 1,25-dihydroxyvitamin D

Vitamin D Supplementation and Breastfeed Infants

Exclusive breastfeeding has been proven to be the best sole source of nutrition for infants until six months of age when supplemental foods may be added. Controversies have arisen regarding the necessity for vitamin D supplementation prior to six months of age in exclusively breastfed infants. There are inconsistent practices and information provided to parents regarding the need to provide vitamin D supplementation to their infants. Therefore, the puqJose of this project was to determine the cmTent evidence for vitamin D supplementation in exclusively breastfed infants in the first six months of life. Current evidence supports supplementing exclusively breastfed infants with vitamin D regardless of skin color, latitude, or maternal vitamin D status. A comprehensive review of the literature was completed to determine the current evidence for vitamin D supplementation in infants. Six areas were investigated including: health problems associated with low intake of vitamin D, cmTent guidelines for vitamin D intake, the composition of breastmilk, pharmacodynamics and pharmacokinetics of vitamin D, and the appropriateness of supplementation and current healthcare provider practices. The main focus of this project was primarily on practice discrepancies amongst health care providers regarding the recommendation of vitamin D supplementation. At the culmination of this project, local providers were educated about current evidence and guidelines srnTounding vitamin D supplementation and breastfed infants in an attempt to influence standards of practic

Vitamin D and antimicrobial peptide levels in patients with atopic dermatitis and atopic dermatitis complicated by eczema herpeticum: A pilot study.

In this study, Vitamin D supplementation results in improved clinical severity of atopic dermatitis and increased skin surface LL-37 levels, analyzed by a novel, non-invasive method. Vitamin D supplementation could be a therapeutic option in AD

Effect of vitamin D supplementation to prevent acute respiratory tract infection : an evidence-based case report

Background: One of the frequent health problems that regularly occurs in Indonesia, as a tropical country is an acute respiratory tract infection, including influenza. Since immunological benefit of vitamin D already proven, hypothetically, vitamin D can be used as protective agent to prevent influenza or other respiratory tract infections. Objective: This evidence-based case report was focused on the evaluation of protective ability of vitamin D supplementation to prevent influenza or other acute respiratory tract infections.Methods: Literature searching was conducted on PubMed data base and Cochrane Library using the related keyword combinations.Results: Two randomized-clinical trials (RCTs) and a meta-analysis study were fulfilled the eligibility criteria. Vitamin D supplementation did not reduce the incidence of influenza but reduce the incidence of non-influenza infection. High-dose vitamin D supplementation had no effect on the reduction of acute respiratory tract infection incidence. The meta-analysis concluded that vitamin D supplementation reduced the risk for acute respiratory tract infection and the stronger effects occurred on low-levels of vitamin D serum.Conclusion: Vitamin D supplementation may prevent acute respiratory tract infections, especially in subjects with low-levels of vitamin D serum

VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health

Introduction Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6&ndash;8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. Methods nd analysis Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D &lt;50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited