A systematic review protocol examining the effect of vitamin D supplementation on endothelial function Effect of vitamin D supplementation on inflammation: protocol for a systematic review Successful knowledge translation intervention in long-term care: final results from the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial An interdisciplinary knowledge translation intervention in long-term care: Study protocol for the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS). The D-Health Trial: A randomized trial of vitamin D for prevention of mortality and cancer. Vitamin D accelerates resolution of inflammatory responses during tuberculosis treatment Vitamin D supplementation for severe pneumonia — A randomized controlled trial Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3 Supplementation in Human Immunodeficiency Virus-Infected Children and Young Adults. Vitamin D3 supplementation in HIV infection: effectiveness and associations with antiretroviral therapy Vitamin D supplementation in the treatment of atopic dermatitis: a clinical trial study. Vitamin D supplementation in the prevention and management of major chronic diseases not related to mineral homeostasis in adults: research for evidence and a scientific statement from the European society for clinical and economic aspects of osteoporosis and osteoarthritis (ESCEO) High-dose Vitamin D3 Supplementation in Children and Young Adults with HIV: A Randomized, Placebo-controlled Trial World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Vitamin D Adjunctive vitamin D for treatment of active tuberculosis in India: a randomised, double-blind, placebo-controlled trial. Prevention of urinary tract infections with vitamin D supplementation 20,000 IU per week for five years. Results from an RCT including 511 subjects
Introduction Vitamin D has potential benefits for extraskeletal health . These could include an anti-inflammatory effect as well as a reduction in endothelial dysfunction . We aim to provide quality evidence for the hypothesis that supplementation with vitamin D will improve endothelial function ( EF ) , possibly through the abrogation of systemic inflammation . Methods and analysis We will conduct a systematic review of all r and omised controlled trials on  vitamin D supplementation and EF lasting 12 weeks or more . The search will cover the period 2000–2015 and include studies that describe direct measures of EF  , markers of endothelial cell ( EC ) activation  and if concurrently reported , indicators of systemic inflammation  . Study selection will follow the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines and study quality will be assessed by the Jadad score in addition to an evaluation of allocation concealment and data analysis . If sufficient data are available , a meta- analysis will be conducted . The effect sizes will be generated using Hedges ’ g score , for both fixed and r and om effect models . I2 statistics and Galbraith plots will be used to assess heterogeneity and identify their potential sources . Potential publication and small sample size bias will be assessed by visual inspections of funnel plots and also Egger 's test . Meta-regression analysis ( if feasible ) will be conducted with restricted maximum likelihood ( REML ) estimation method , controlling for potential confounders ( demographics , study methods , location , etc ) . A backward elimination process will be applied in the regression modelling procedure . Subgroup analysis , conditional on number of studies retrieved and their sample size , will be stratified on participant disease category , total dose administered , degree of 25(OH)D change and type of supplement used . Ethics and dissemination Formal ethical approval is not required as primary data will not be collected . The results will be disseminated through a peer- review ed publication , conference presentation and the popular press . Trial registration number International Prospect i ve Register for Systematic Review s ( PROSPERO ) number CRD42014013523 Introduction The extraskeletal role of vitamin D is being increasingly recognised . This has important clinical implication s , as vitamin D deficiency has reached epidemic proportions worldwide . Vitamin D has proposed anti-inflammatory properties , yet the role of vitamin D supplementation in reducing inflammation remains largely unknown . The purpose of this review is to investigate the impact of vitamin D supplementation on inflammation , and to identify relevant knowledge gaps in the field . Methods and analysis Medline , CINAHL , EMBASE and All EBM will be systematic ally search ed for r and omised controlled trials ( RCTs ) and systematic review s of RCTs , comparing vitamin D supplementation with placebo , usual care or other pharmacological or non-pharmacological interventions . One review er will assess articles for eligibility according to prespecified selection criteria , after which 2 independent review ers will perform data extraction and quality appraisal . Meta-analyses will be conducted where appropriate . Ethics and dissemination Formal ethical approval is not required as no primary data is collected . This systematic review will identify potential clinical implication s of vitamin D deficiency and supplementation , and will be disseminated through a peer- review ed publication and at conference meetings , to inform future research on the efficacy of vitamin D supplementation for inflammation and inflammatory diseases . PROSPERO registration number CRD42016037104 Background Few studies have systematic ally examined whether knowledge translation ( KT ) strategies can be successfully implemented within the long-term care ( LTC ) setting . In this study , we examined the effectiveness of a multifaceted , interdisciplinary KT intervention for improving the prescribing of vitamin D , calcium and osteoporosis medications over 12-months . Methods We conducted a pilot , cluster r and omized controlled trial in 40 LTC homes ( 21 control ; 19 intervention ) in Ontario , Canada . LTC homes were eligible if they had more than one prescribing physician and received services from a large pharmacy provider . Participants were interdisciplinary care teams ( physicians , nurses , consultant pharmacists , and other staff ) who met quarterly . Intervention homes participated in three educational meetings over 12 months , including a st and ardized presentation led by expert opinion leaders , action planning for quality improvement , and audit and feedback review . Control homes did not receive any additional intervention  . Resident-level prescribing and clinical outcomes were collected from the pharmacy data base ; data collectors and analysts were blinded . In addition to feasibility measures , study outcomes were the proportion of residents taking vitamin D ( ≥800 IU/daily ; primary ) , calcium ≥500 mg/day and osteoporosis medications ( high-risk residents ) over 12 months . Data were analyzed using the generalized estimating equations technique accounting for clustering within the LTC homes . Results At baseline , 5,478 residents , mean age 84.4 ( st and ard deviation ( SD ) 10.9 ) , 71 % female , resided in 40 LTC homes , mean size = 137 beds ( SD 76.7 ) . In the intention-to-treat analysis ( 21 control ; 19 intervention clusters ) , the intervention result ed in a significantly greater increase in prescribing from baseline to 12 months between intervention versus control arms for vitamin D ( odds ratio ( OR ) 1.82 , 95 % confidence interval ( CI ) : 1.12 , 2.96 ) and calcium ( OR 1.33 , 95 % CI : 1.01 , 1.74 ) , but not for osteoporosis medications ( OR 1.17 , 95 % CI : 0.91 , 1.51 ) . In secondary analyses , excluding seven nonparticipating intervention homes , ORs were 3.06 ( 95 % CI : 2.18 , 4.29 ) , 1.57 ( 95 % CI : 1.12 , 2.21 ) , 1.20 ( 95 % CI : 0.90 , 1.60 ) for vitamin D , calcium and osteoporosis medications , respectively . Conclusions Our KT intervention significantly improved the prescribing of vitamin D and calcium and is a model that could potentially be applied to other areas requiring quality improvement . Trial Registration Clinical Trials.gov : NCT01398527 . Registered : 19 July 2011 Background Knowledge translation ( KT ) research in long-term care ( LTC ) is still in its early stages . This protocol describes the evaluation of a multifaceted , interdisciplinary KT intervention aim ed at integrating evidence -based osteoporosis and fracture prevention strategies into LTC care processes . Methods and design The Vitamin D and Osteoporosis Study ( ViDOS ) is underway in 40 LTC homes ( n = 19 intervention , n = 21 control ) across Ontario , Canada . The primary objectives of this study are to assess the feasibility of delivering the KT intervention , and clinical ly , to increase the percent of LTC residents prescribed ≥800 IU of vitamin D daily . Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician . The target audience within each LTC home is the Professional Advisory Committee ( PAC ) , an interdisciplinary team who meets quarterly . The key elements of the intervention are three interactive educational sessions led by an expert opinion leader , action planning using a quality improvement cycle , audit and feedback reports , nominated internal champions , and reminders/point-of-care tools . Control homes do not receive any intervention , however both intervention and control homes received educational material s as part of the Ontario Osteoporosis Strategy . Primary outcomes are feasibility measures ( recruitment , retention , attendance at educational sessions , action plan items identified and initiated , internal champions identified , performance reports provided and review ed ) , and vitamin D ( ≥800 IU/daily ) prescribing at 6 and 12 months . Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications , and falls and fractures . Qualitative methods will examine the experience of the LTC team with the KT intervention . Homes are central ly r and omized to intervention and control groups in blocks of variable size using a computer generated allocation sequence . R and omization is stratified by home size and profit/nonprofit status . Prescribing data retrieval and analysis are performed by blinded personnel . Discussion Our study will contribute to an improved underst and ing of the feasibility and acceptability of a multifaceted intervention aim ed at translating knowledge to LTC practitioners . Lessons learned from this study will be valuable in guiding future research and underst and ing the complexities of translating knowledge in LTC.Trial registration Clinical Trials.gov NCT01398527 OBJECTIVES To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge . DESIGN Multicenter , r and omized , controlled trial with a factorial design . SETTING Five hospitals in Auckl and , New Zeal and , and Sydney , Australia . PARTICIPANTS Two hundred forty-three frail older people . INTERVENTIONS Patients were r and omized to receive a single dose of vitamin D ( calciferol , 300,000 IU ) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits . MEASUREMENTS The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months . Physical performance and self-rated function were secondary endpoints . Assessment s took place in the participants ' homes at 3 and 6 months after r and omization and were performed by blinded assessors . RESULTS There was no effect of either intervention on physical health or falls , but patients in the exercise group were at increased risk of musculoskeletal injury ( risk ratio = 3.6 , 95 % confidence interval = 1.5 - 8.0 ) . Vitamin D supplementation did not improve physical performance , even in those who were vitamin D deficient ( < 12 ng/mL ) at baseline . CONCLUSION Neither vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization . There was no effect of vitamin D on physical performance , and the exercises increased the risk of musculoskeletal injury . These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people BACKGROUND Vitamin D , specifically serum 25(OH)D has been associated with mortality , cancer and multiple other health endpoints in observational studies , but there is a paucity of clinical trial evidence sufficient to determine the safety and effectiveness of population -wide supplementation . We have therefore launched the D-Health Trial , a r and omized trial of vitamin D supplementation for prevention of mortality and cancer . Here we report the methods and describe the trial cohort . METHODS The D-Health Trial is a r and omized placebo-controlled trial , with planned intervention for 5years and a further 5years of passive follow-up through linkage with health and death registers . Participants aged 65 - 84years were recruited from the general population of Australia . The intervention is monthly oral doses of 60,000IU of cholecalciferol or matching placebo . The primary outcome is all-cause mortality . Secondary outcomes are total cancer incidence and colorectal cancer incidence . RESULTS We recruited 21,315 participants to the trial between February 2014 and May 2015 . The participants in the two arms of the trial were well-balanced at baseline . Comparison with Australian population statistics shows that the trial participants were less likely to report being in fair or poor health , to be current smokers or to have diabetes than the Australian population . However , the proportion overweight or with health conditions such as arthritis and angina was similar . CONCLUSIONS Observational data can not be considered sufficient to support interventions delivered at a population level . Large-scale r and omized trials such as the D-Health Trial are needed to inform public health policy and practice Calcidiol , the major circulating metabolite of vitamin D , supports induction of pleiotropic antimicrobial responses in vitro . Vitamin D supplementation elevates circulating calcidiol concentrations , and thus has a potential role in the prevention and treatment of infection . The immunomodulatory effects of administering vitamin D to humans with an infectious disease have not previously been reported . To characterize these effects , we conducted a detailed longitudinal study of circulating and antigen-stimulated immune responses in ninety-five patients receiving antimicrobial therapy for pulmonary tuberculosis who were r and omized to receive adjunctive high-dose vitamin D or placebo in a clinical trial , and who fulfilled criteria for per- protocol analysis . Vitamin D supplementation accelerated sputum smear conversion and enhanced treatment-induced resolution of lymphopaenia , monocytosis , hypercytokinaemia , and hyperchemokinaemia . Administration of vitamin D also suppressed antigen-stimulated proinflammatory cytokine responses , but attenuated the suppressive effect of antimicrobial therapy on antigen-stimulated secretion of IL-4 , CC chemokine lig and 5 , and IFN-α . We demonstrate a previously unappreciated role for vitamin D supplementation in accelerating resolution of inflammatory responses during tuberculosis treatment . Our findings suggest a potential role for adjunctive vitamin D supplementation in the treatment of pulmonary infections to accelerate resolution of inflammatory responses associated with increased risk of mortality Objective To determine the role of oral vitamin D supplementation for resolution of severe pneumonia in under-five children . Design R and omized , double blind , placebo-controlled trial . Setting In patients from a tertiary care hospital . Participants Two hundred children [ mean ( SD ) age : 13.9 ( 11.7 ) months ; boys : 120 ] between 2 months to 5 years with severe pneumonia . Pneumonia was diagnosed in the presence of fever , cough , tachypnea ( as per WHO cut-offs ) and crepitations . Children with pneumonia and chest indrawing or at least one of the danger sign ( inability to feed , lethargy , cyanosis ) were diagnosed as having severe pneumonia . The two groups were comparable for baseline characteristics including age , anthropometry , socio-demographic profile , and clinical and laboratory parameters . InterventionOral vitamin D ( 1000 IU for < 1 year and 2000 IU for > 1 year ) ( n=100 ) or placebo ( lactose ) ( n=100 ) once a day for 5 days , from enrolment . Both the groups received antibiotics as per the Indian Academy of Pediatrics guidelines , and supportive care ( oxygen , intravenous fluids and monitoring ) . Outcome variables Primary : time to resolution of severe pneumonia . Secondary : duration of hospitalization and time to resolution of tachypnea , chest retractions and inability to feed . Results Median duration ( SE , 95 % CI ) of resolution of severe pneumonia was similar in the two groups [ vitamin D : 72 ( 3.7 , 64.7–79.3 ) hours ; placebo : 64 ( 4.5 , 55.2–72.8 ) hours ] . Duration of hospitalization and time to resolution of tachypnea , chest retractions , and inability to feed were also comparable between the two groups . ConclusionS hort-term supplementation with oral vitamin D ( 1000–2000 IU per day for 5 days ) has no beneficial effect on resolution of severe pneumonia in under-five children . Further studies need to be conducted with higher dose of Vitamin D or longer duration of supplementation to corroborate these findings Introduction Osteoporotic fractures in older people are a major and increasing public health problem . We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation . Methods In a pragmatic double blind r and omised controlled trial of 3 years duration , we examined 3,440 people ( 2,624 women and 816 men ) living in residential or care home . We used four-monthly oral supplementation using 100,000 IU vitamin D2 ( ergocalciferol ) . As a main outcome measure , we used the incidence of first fracture using an intention to treat analysis . This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales , UK . Results The vitamin D and placebo groups had similar baseline characteristics . In intention-to-treat analysis , 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up ( 7 fractures per 100 people per year of follow-up ) , with 218 first fractures in the control group over 2,860 person years of follow-up . The hazard ratio of 0.95 ( 95 % confidence interval 0.79–1.15 ) for intervention compared to control was not statistically significant . ConclusionS upplementation with four-monthly 100,000 IU of oral vitamin D2 is not sufficient to affect fracture incidence among older people living in institutional care BACKGROUND There is uncertainty whether long-term daily dosing with vitamin D3 ( cholecalciferol ) supplementation ( vitD3 ) above the 4000-IU/d dietary reference intake upper tolerable limit in children and adults is safe . As part of a r and omized placebo-controlled trial , we determined if supplementation with 7000-IU/d vitD3 for 12 months in human immunodeficiency virus (HIV)-Infected subjects was safe and /or associated with metabolic outcomes . MATERIAL AND METHODS A total of 58 HIV-infected subjects-aged 9 - 24.9 years and stratified by mode of HIV acquisition ( perinatal or behavioral)-were recruited , r and omized to 7000-IU/d vitD3 or placebo , and followed at 3 , 6 , and 12 months with physical examinations , blood and urine sampling for measures of 25(OH)D ( serum 25-hydroxyvitamin D ) , metabolic status , safety measures , and HIV immune status . Safety was defined by a low incidence ( < 5 % ) of the study -defined serious adverse events-that is , elevated serum calcium plus 25(OH)D > 160 ng/mL- and no changes in hematologic , liver , renal , metabolic , lipid , or inflammatory status . RESULTS R and omization groups did not differ in demographic characteristics , vitamin D status , or HIV disease status at baseline . Over the 12 months , serum 25(OH)D increased with supplementation . No subject experienced a serious adverse safety event ; none had 25(OH)D > 80 ng/mL at any time . There were no clinical ly significant changes in hematologic , liver , renal , metabolic , lipid , or inflammatory status . CONCLUSIONS Safety of daily 7000-IU vitD3 supplementation in children and young adults with HIV was comprehensively monitored over 12 months . High-dose daily vitD3 supplementation was efficacious in improving vitamin D status , and there were no safety events Background HIV infection and antiretroviral therapy ( ART ) may create unique risk factors for vitamin D insufficiency , including alterations of vitamin D metabolism by ART . We prospect ively compared demographic and clinical parameters between vitamin D sufficient and insufficient HIV-infected ( HIV+ ) adults , and assessed changes in these parameters among insufficient participants following st and ardized vitamin D supplementation . Methods HIV+ adults ( ≥18 years old ) with HIV-1 RNA < 50 copies/mL on ART were enrolled . Vitamin D sufficiency and insufficiency were defined as 25-hydroxyvitamin D ( 25(OH)D ) ≥30 or < 30 ng/mL , respectively . Insufficient participants received open-label vitamin D3 50,000 IU twice weekly for 5 weeks , then 8000 IU twice weekly to complete 24 weeks . The primary endpoint was success or failure to achieve 25(OH)D ≥30 ng/mL at week 24 . Results Ninety-seven participants enrolled ( 34 vitamin D sufficient , 63 insufficient ) ; 32 % female , 47 % non-White , median age 46 years , ART duration 5 years , CD4 + T lymphocyte count ( CD4 ) 673 cells/mm3 . 25(OH)D repletion was 83 % ( 95 % CI 71 % –90 % ) successful . 25(OH)D levels correlated with both CD4 ( r = 0.44 , p = 0.01 ) and time on protease inhibitor ( r = −0.35 , p = 0.01 ) . After adjusting for age , sex , race , nadir CD4 and baseline 25(OH)D : 1 ) current use of efavirenz exposure was associated with a 21.1 ng/mL higher week 24 25(OH)D level ( p = 0.007 ) , 2 ) per year use of zidovudine was associated with 7.1 ng/mL reduction in week 24 serum 25(OH)D ( p = 0.05 ) and 3 ) every 1 ng/mL 25(OH)D increase was associated with a 3.3 cell/mm3 CD4 increase ( p = 0.06 ) . Conclusion Vitamin D3 supplementation was effective in repleting 25(OH)D levels after 24 weeks . Current efavirenz use was positively associated with post-repletion 25(OH)D levels , while greater time on zidovudine was associated with lower post-repletion 25(OH)D levels . The association between improved CD4 recovery and vitamin D repletion suggests a potential benefit of vitamin D supplementation on immunologic recovery during HIV treatment . Trial registration This trial is registered at The Brazilian Clinical Trials Registry ( U1111‐1165‐2537 ) BACKGROUND The role of vitamin D in Atopic Dermatitis ( AD ) is ambiguous and clinical trials are needed to assess the role of vitamin D in the treatment of AD . The aim of this clinical trial study to evaluate the effect of vitamin D supplementation on patients with AD . MATERIAL AND METHODS sixty AD patients were included in a r and omized , double-blind , placebo-controlled trial study . They were r and omly divided into two groups and treated for 60 days : group vitamin D ( n=30 ) , and placebo group ( n=30 ) . The two groups were as follows : Group D , 1600 IU cholecalciferol ( vitamin D ) and second group placebo . The severity of AD was evaluated based on SCORAD ( Scoring Atopic Dermatitis ) and TIS ( Three Item Severity score ) value by the same trained physician before and after the trial . RESULTS According to SCORAD and TIS value index in the vitamin D group showed significant improvement in patients with mild , moderate and severe AD ( P<0.05 ) and in patients who the intake placebo , this improvement did n't showed ( P>0.05 ) . CONCLUSION Results mention that supplementation with oral vitamin D dramatically improved disease severity in AD patients Introduction Optimal vitamin D status promotes skeletal health and is recommended with specific treatment in individuals at high risk for fragility fractures . A growing body of literature has provided indirect and some direct evidence for possible extraskeletal vitamin D-related effects . Purpose and Methods Members of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis have review ed the main evidence for possible proven benefits of vitamin D supplementation in adults at risk of or with overt chronic extra-skeletal diseases , providing recommendations and guidelines for future studies in this field . Results and conclusions Robust mechanistic evidence is available from in vitro studies and in vivo animal studies , usually employing cholecalciferol , calcidiol or calcitriol in pharmacologic rather than physiologic doses . Although many cross-sectional and prospect i ve association studies in humans have shown that low 25-hydroxyvitamin D levels ( i.e. , < 50 nmol/L ) are consistently associated with chronic diseases , further strengthened by a dose-response relationship , several meta-analyses of clinical trials have shown contradictory results . Overall , large r and omized controlled trials with sufficient doses of vitamin D are missing , and available small to moderate-size trials often included people with baseline levels of serum 25-hydroxyvitamin D levels  > 50 nmol/L , did not simultaneously assess multiple outcomes , and did not report overall safety ( e.g. , falls ) . Thus , no recommendations can be made to date for the use of vitamin D supplementation in general , parental compounds , or non-hypercalcemic vitamin D analogs in the prevention and treatment of extra-skeletal chronic diseases . Moreover , attainment of serum 25-hydroxyvitamin D levels well above the threshold desired for bone health can not be recommended based on current evidence , since safety has yet to be confirmed . Finally , the promising findings from mechanistic studies , large cohort studies , and small clinical trials obtained for autoimmune diseases ( including type 1 diabetes , multiple sclerosis , and systemic lupus erythematosus ) , cardiovascular disorders , and overall reduction in mortality require further confirmation Background : Suboptimal vitamin D status is prevalent in HIV-infected patients and associated with increased risk of disease severity and morbidity . We aim ed to determine 12-month safety and efficacy of daily 7000 IU vitamin D3 ( vitD3 ) versus placebo to sustain increased serum 25-hydroxyvitamin D ( 25(OH)D ) and improve immune status in HIV-infected subjects . Methods : This was a double-blind trial of perinatally acquired HIV (PHIV)-infected subjects or behaviorally acquired HIV (BHIV)-infected subjects ( 5.0 - 24.9 years ) .  Safety , 25(OH)D-related parameters and immune status were assessed at baseline , 3 , 6 and 12 months . Results : Fifty-eight subjects enrolled ( 67 % male , 85 % African American and 64 % BHIV ) and 50 completed with no safety concerns .  In unadjusted analyses , there were no differences between r and omization groups at baseline ; at 3 , 6 and 12 months , 25(OH)D was higher with supplementation than baseline and higher than with placebo ( P < 0.05 ) . In adjusted mixed models , in the supplementation group , the fixed effect of 25(OH)D was higher ( P < 0.001 ) . Percentage of naive T-helper cells ( Th naive% ) were significantly ( P < 0.01 ) and T-helper cells ( CD4 % ) marginally ( P < 0.10 ) increased with supplementation in those taking highly active antiretroviral therapy ( HAART ) , and RNA viral load was reduced ( P ⩽ 0.05 ) . In exploratory linear models , change in 25(OH)D predicted RNA viral load at 3 and 12 months and CD4 % at 3 months ( P < 0.05 ) . Conclusions : Daily 7000 IU vitD3 for 12 months was safe in HIV-infected subjects and effective in increasing 25(OH)D. Supplementation improved some clinical ly important HIV immune markers in subjects on HAART . Adjunct therapy with high-dose , daily vitD3 for HIV-infected subjects and for those on/off HAART requires further investigation Background The prevalence of allergic diseases is approximately 10 % in infants whose parents and siblings do not have allergic diseases and 20–30 % in those with an allergic first-degree relative .  Vitamin D is involved in the regulation of the immune system and it may play a role in the development , severity and course of asthma and other allergic diseases . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations addressing the use of vitamin D in primary prevention of allergic diseases . Methods Our WAO guideline panel identified the most relevant clinical questions and performed a systematic review of r and omized controlled trials and non-r and omized studies ( NRS ) , specifically cohort and case-control studies , of vitamin D supplementation for the prevention of allergic diseases . We also review ed the evidence about values and preferences , and re source requirements ( up to January 2015 , with an up date on January 30 , 2016 ) . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . Results Having review ed the currently available evidence , the WAO guideline panel found no support for the hypothesis that vitamin D supplementation reduces the risk of developing allergic diseases in children . The WAO guideline panel suggest not using vitamin D in pregnant women , breastfeeding mothers , or healthy term infants as a means of preventing the development of allergic diseases . This recommendation does not apply to those mothers and infants who have other indications for prophylactic or therapeutic use of vitamin D. The panel ’s recommendations are conditional and supported by very low certainty evidence . Conclusions WAO recommendations about vitamin D supplementation for the prevention of allergic diseases support parents , clinicians and other health care professionals in their decisions whether or not to use vitamin D in preventing allergic diseases in healthy , term infants BACKGROUND Vitamin D has immunomodulatory effects that might aid clearance of mycobacterial infection . We aim ed to assess whether vitamin D supplementation would reduce time to sputum culture conversion in patients with active tuberculosis . METHODS We did this r and omised , double-blind , placebo-controlled , superiority trial at 13 sites in India . Treatment-naive patients who were sputum-smear positive , HIV negative , and had pulmonary tuberculosis were r and omly assigned ( 1:1 ) , with central ly labelled , serially numbered bottles , to receive st and ard active tuberculosis treatment with either supplemental high-dose oral vitamin D3 ( four doses of 2·5 mg at weeks 0 , 2 , 4 , and 6 ) or placebo . Neither the patients nor the clinical and laboratory investigators and personnel were aware of treatment assignment . The primary efficacy outcome was time to sputum culture conversion . Analysis was by modified intention to treat . This trial is registered with Clinical Trials.gov , number NCT00366470 . FINDINGS Between Jan 20 , 2010 , and Aug 23 , 2011 , we r and omly assigned 247 participants to the vitamin D group ( n=121 ) or the placebo group ( n=126 ) , of whom 211 participants ( n=101 and n=110 , respectively ) were included in the primary efficacy  analysis . Median time to culture conversion in the vitamin D group was 43·0 days ( 95 % CI 33·3 - 52·8 ) versus 42·0 days ( 33·9 - 50·1 ) in the placebo group ( log-rank p=0·95 ) . Three ( 2 % ) patients died in the vitamin D group and one ( 1 % ) patient died in the placebo group ; no death was considered attributable to the study intervention . No patients had hypercalcaemia . INTERPRETATION Our findings show that vitamin D supplementation did not reduce time to sputum culture conversion . Further studies should investigate the role of vitamin D in prevention or reactivation of tuberculosis infection . FUNDING Dalhousie University and Infectious Diseases Training and Research Centre Abstract Background : In observational studies vitamin D deficiency is associated with increased risk of infections , whereas the effect of vitamin D supplementation in r and omized controlled trials is non-conclusive . Methods : Five hundred and eleven subjects with prediabetes were r and omized to vitamin D3 ( 20,000 IU per week ) versus placebo for five years . Every sixth month , a question naire on respiratory tract infections ( RTI ) ( common cold , bronchitis , influenza ) and urinary tract infection ( UTI ) was filled in . Results : Mean baseline serum 25-hydroxyvitamin D ( 25(OH)D ) level was 60 nmol/L. Two hundred and fifty-six subjects received vitamin D and 255 placebo . One hundred and sixteen subjects in the vitamin D and 111 in the placebo  group completed the five-year study . Eighteen subjects in the vitamin D group and 34 subjects in the placebo group reported UTI during the study ( p < 0.02 ) , whereas no significant differences were seen for RTI . The effect on UTI was most pronounced in males . The effect of vitamin D on UTI was unrelated to baseline serum 25(OH)D level . Conclusion : Supplementation with vitamin D might prevent UTI , but confirmatory studies are needed
Serious adverse events attributable to vitamin D supplementation were rare across all studies .
On the basis of studies review ed to date , the strongest evidence supports further research into adjunctive vitamin D therapy for tuberculosis , influenza , and viral upper respiratory tract illnesses .
OBJECTIVE To review the existing human controlled intervention studies of vitamin D as adjunctive therapy in setting s of infection and provide recommendations for design and implementation of future studies in this field on the basis of the evidence review ed .