A Treatment Trial of Vitamin D Supplementation in Breast-fed Infants: Universal Supplementation Is Not Necessary for Rickets Prevention in Southern Louisiana Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial. Vitamin D supplementation in breastfed infants from Montréal, Canada: 25-hydroxyvitamin D and bone health effects from a follow-up study at 3 years of age Prospective study of vitamin D supplementation and rickets in China. Double Blind Study on the Need for Vitamin D Supplementation in Prepubertal Children Effect of vitamin D supplementation, directly or via breast milk for term infants, on serum 25 hydroxyvitamin D and related biochemistry, and propensity to infection: a randomised placebo-controlled trial. Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant. Effect of combined maternal and infant vitamin D supplementation on vitamin D status of exclusively breastfed infants. Effect of free vitamin D2 drops on serum 25-hydroxyvitamin D in infants with immigrant origin: a cluster randomized controlled trial World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Vitamin D Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial Bone mineral content and serum 25-hydroxyvitamin D concentration in breast-fed infants with and without supplemental vitamin D. [Prophylaxis of vitamin D deficiency in hypothyroidism in the newborn infant]. Response of vitamin D binding protein and free vitamin D concentrations to vitamin D supplementation in hospitalized premature infants Vitamin D and health in pregnancy, infants, children and adolescents in Australia and New Zealand: a position statement. Effect on the incidence of pneumonia of vitamin D supplementation by quarterly bolus dose to infants in Kabul: a randomised controlled superiority trial DO IT Trial: vitamin D Outcomes and Interventions in Toddlers – a TARGet Kids! randomized controlled trial
This study was conducted to determine if vitamin D supplementation is required to prevent rickets in breast-fed infants . Breast-feeding rates are increasing , and there are concerns about whether the vitamin D content of breast milk is sufficient . There are a few treatment trials of vitamin D supplementation in breast-fed infants ; these were conducted in northern climates . The authors therefore performed a prospect i ve clinical trial comparing vitamin D supplementation with placebo as control in southern Louisiana . Blood sample s and question naires were collected at birth , 2 , 4 , and 6 months of age . There were no cases of rickets observed , and no differences in alkaline phosphatase levels between groups . Thus , there was no evidence that vitamin D supplementation reduced rickets risk in the authors ’ study population . This suggests that the current recommendations for universal vitamin D supplementation of breast-fed infants throughout the United States may need to be revised IMPORTANCE Vitamin D supplementation in infancy is required to support healthy bone mineral accretion . A supplement of 400 IU of vitamin D per day is thought to support plasma 25-hydroxyvitamin D ( 25[OH]D ) concentrations between 40 and 50 nmol/L ; some advocate 75 to 150 nmol/L for bone health . OBJECTIVE To investigate the efficacy of different dosages of vitamin D in supporting 25(OH)D concentrations in infants . DESIGN , SETTING , AND PARTICIPANTS Double-blind r and omized clinical trial conducted among 132 one-month-old healthy , term , breastfed infants from Montréal , Québec , Canada , between March 2007 and August 2010 . Infants were followed up for 11 months ending August 2011 ( 74 % completed study ) . INTERVENTION Participants were r and omly assigned to receive oral cholecalciferol ( vitamin D3 ) supplements of 400 IU/d ( n=39 ) , 800 IU/d ( n=39 ) , 1200 IU/d ( n=38 ) , or 1600 IU/d ( n=16 ) . MAIN OUTCOMES AND MEASURES The primary outcome was a plasma 25(OH)D concentration of 75 nmol/L or greater in 97.5 % of infants at 3 months . Secondary outcomes included 25(OH)D concentrations of 75 nmol/L or greater in 97.5 % of infants at 6 , 9 , and 12 months ; 25(OH)D concentrations of 50 nmol/L or greater across all times ; growth ; and whole body and regional bone mineral content . Data were analyzed by intention to treat using available data , logistic regression , and mixed-model analysis of variance . RESULTS By 3 months , 55 % ( 95 % CI , 38%-72 % ) of infants in the 400-IU/d group achieved a 25(OH)D concentration of 75 nmol/L or greater vs 81%(95 % CI , 65%-91 % ) in the 800-IU/d group , 92 % ( 95 % CI , 77%-98 % ) in the 1200-IU/d group , and 100 % in the 1600-IU/d group . This concentration was not sustained in 97.5 % of infants at 12 months in any of the groups . The 1600-IU/d dosage was discontinued prematurely because of elevated plasma 25(OH)D concentrations . All dosages established 25(OH)D concentrations of 50 nmol/L or greater in 97 % ( 95 % CI , 94%-100 % ) of infants at 3 months and sustained this in 98 % ( 95 % CI , 94%-100 % ) to 12 months . Growth and bone mineral content did not differ by dosage . CONCLUSIONS AND RELEVANCE Among healthy , term , breastfed infants , only a vitamin D supplement dosage of 1600 IU/d ( but not dosages of 400 , 800 , or 1200 IU/d ) increased plasma 25(OH)D concentration to 75 nmol/L or greater in 97.5 % of infants at 3 months . However , this dosage increased 25(OH)D concentrations to levels that have been associated with hypercalcemia . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00381914 Summary Whether infant vitamin D supplementation may have long-term bone benefits is unclear . In this study , breastfed infants who received vitamin dosages greater than 400 IU/day did not have higher bone mineralization at 3 years . This study provides important data to inform pediatric public health recommendations for vitamin D. Introduction North American health agencies recommend breastfed infants should be supplemented with 400 IU of vitamin D/day to support bone health . Few studies examined the long-term benefits of early life vitamin D supplementation on bone mineralization . The objective of this study was to determine if a dose-response relationship exists between infant vitamin D supplementation , vitamin D status , and bone outcomes at 3 years of age . Methods This was a double-blind r and omized trial of 132 , 1-month-old healthy , breastfed infants from Montréal , Canada , between 2007 and 2010 . In this longitudinal analysis , 87 infants ( 66 % ) returned for follow-up at 3 years of age , between 2010 and 2013 . At 1 month of age , participants were r and omly assigned to receive oral cholecalciferol ( vitamin D3 ) supplements of 400 , 800 , 1200 , or 1600 IU/day until 12 months of age . Lumbar spine vertebrae 1–4 ( LS ) bone mineral density ( BMD ) , LS and whole body bone mineral content ( BMC ) , and mineral accretion were measured by dual-energy x-ray absorptiometry at 3 years . Results At follow-up , the treatment groups were similar in terms of diet , sun exposure , and demographics . There were no significant differences among the groups in LS or whole body BMC , BMD , or accretion . Although , 25(OH)D concentrations were not different among the groups , higher doses ( 1200 and 1600 IU/day ) achieved higher 25(OH)D area under the curve from 1 to 36 months vs. 400 IU/day . Conclusions This is the first longitudinal follow-up of an infant vitamin D dose-response study which examines bone mineralization at 3 years of age . Dosages higher than 400 IU/day do not appear to provide additional benefits to the bone at follow-up . Larger studies with more ethnically diverse groups are needed to confirm these results To determine whether amounts of vitamin D lower than recommended doses are effective in preventing rickets , 256 term infants from two northern and two southern cities in China were studied in a r and omized trial of vitamin D supplementation ( 100 , 200 , or 400 IU/day ) during the first 6 months of life . Cord blood and 6-month blood sample s were collected and radiographs were obtained at 3 to 5 days and at 6 months of age . Cord serum 25-hydroxyvitamin D concentrations were lower in the north than in the south ( 5 vs 14 ng/ml ( 12.5 vs 35.0 nmol/L ) ; p less than 0.01 ) . Wrist ossification centers were less likely to be present at birth in the northern children than in the southern children ( p = 0.009 ) and were more likely to be present in infants born in the fall who had higher cord serum concentrations of 25-hydroxyvitamin D ( p = 0.04 ) . Serum 25-hydroxyvitamin D concentrations were lower in northern children 6 months of age than in southern children ( p = 0.005 ) and were higher with an increasing supplemental dosage of vitamin D ( p less than 0.001 ) , particularly in infants in the north . None of the infants had rickets at 6 months of age . Because of the low serum 25-hydroxyvitamin D concentrations , especially among infants in the north , it may be prudent to supplement the diet with vitamin D at a dose of 400 IU/day ABSTRACT . Fifty‐one healthy prepubertal schoolchildren were followed for 13 months in a double blind study . Twenty‐four of them were supplemented with 400 IU of vitamin D2 5–7 times weekly , while 27 received a placebo . The children were examined in winter both at the beginning and at the end of the study , and in the middle of the study in autumn . Mean 25‐hydroxyvitamin D levels in the supplemented group were significantly higher than those in the placebo group both in autumn and in winter , when the study ended . The vitamin D supplementation did not , however , affect other vitamin D metabolites , serum calcium , albumin , inorganic phosphorus , parathyroid hormone concentrations or alkaline phosphatase activity . Moreover , the supplementation caused no alterations in the weight or height gain or bone mineral content of the distal radius of the children , and thus sub clinical rickets could not be shown We assessed the effect of vitamin D supplementation on related biochemistry , infection and dentition of the infant . In a double-blind , placebo-controlled trial conducted in Lucknow , India ( latitude 26 ° N ) , 230 mother -newborn pairs were r and omised to receive , for 9 months , 3000µg/month oral vitamin D3 by the mother ( group A ) or 10µg/d by the infant ( group B ) or double placebo ( group C ) . All babies received 15 min of sun exposure ( unclothed ) during massage . Infants ' median 25-hydroxyvitamin D ( 25(OH)D ) was lower in group C ( median 45·3 ; interquartile range ( IQR ) 22 - 59·5 nmol/l ) than in groups A ( median 60·8 ; IQR 41·3 - 80·5 nmol/l ( P7.5µkat/l ) was significantly more frequent in group C babies ( 16 % ) than in group A ( 4 % ) or group B ( 0 % ) babies . The number of days with respiratory or diarrhoeal infection by 9 months of age was higher in group C ( median 46·5 ; IQR 14·8 - 73·3 d ) than in group A ( median 18·5 ; IQR 8·8 - 31·0 d ( P<0·01 ) ) or group B ( median 13·0 ; IQR 7·0 - 28·5 ( P<0·05 ) ) . We conclude that monthly maternal or daily infant supplementation with vitamin D along with sun exposure is superior to sun exposure alone in maintaining normal infant 25(OH)D at 3·5 months , and provide protection from elevated alkaline phosphatase and infectious morbidity Scientific data pertaining to vitamin D supplementation during lactation are scarce . The daily recommended intake for vitamin D during lactation has been arbitrarily set at 400 IU/d ( 10 microg/d ) . This recommendation is irrelevant with respect to maintaining the nutritional vitamin D status of mothers and nursing infants , especially among darkly pigmented individuals . Our objective was to examine the effect of high-dose maternal vitamin D2 supplementation on the nutritional vitamin D status  of mothers and nursing infants . Fully lactating women ( n = 18 ) were enrolled at 1 mo after birth to 1 of 2 treatment arms , ie , 1600 IU vitamin D2 and 400 IU vitamin D3 ( prenatal vitamin ) or 3600 IU vitamin D2 and 400 IU vitamin D3 , for a 3-mo study period . High-dose ( 1600 or 3600 IU/d ) vitamin D2 supplementation for a period of 3 mo safely increased circulating 25-hydroxyvitamin D [ 25(OH)D ] concentrations for both groups . The antirachitic activity of milk from mothers receiving 2000 IU/d vitamin D increased by 34.2 IU/L , on average , whereas the activity in the 4000 IU/d group increased by 94.2 IU/L. Nursing infant circulating 25(OH)D2 concentrations reflected maternal intake and the amount contained in the milk . With limited sun exposure , an intake of 400 IU/d vitamin D would not sustain circulating 25(OH)D concentrations and thus would supply only limited amounts of vitamin D to nursing infants in breast milk . A maternal intake of 2000 IU/d vitamin D would elevate circulating 25(OH)D concentrations for both mothers and nursing infants , albeit with limited capacity , especially with respect to nursing infants . A maternal intake of 4000 IU/d could achieve substantial progress toward improving both maternal and neonatal nutritional vitamin D status Severe vitamin D deficiency in mothers and their breastfed infants is a significant health problem in the Middle East . Supplementation of the breastfed infant alone with the recommended dose of vitamin D may be insufficient in high-risk population . We investigated the effect of combined maternal and infant vitamin D supplementation on vitamin D status of the breastfed infant . We examined also the effect of supplementation on vitamin D antirachitic activity of breast milk in a subset of mothers . Healthy breastfeeding mothers ( n = 90 ) were r and omly assigned to 2000 IU daily ( group 1 ) or 60,000 IU monthly ( group 2 ) of vitamin D(2 ) , and all their infants ( n = 92 ) received 400 IU daily of vitamin D(2 ) for 3 months . Most infants had vitamin D deficiency - 25-hydroxyvitamin D [ 25(OH)D ] < or= 37.5 nmol L(-1)- at study entry .  Serum 25(OH)D concentrations at 3 months increased significantly from baseline in infants of mothers in group 1 ( 13.9 + /- 8.6 vs. 49.6 + /- 18.5 nmol L(-1 ) , P < 0.0001 ) and group 2 ( 13.7 + /- 12.1 vs. 44.6 + /- 15.0 nmol L(-1 ) , P < 0.0001 ) . Maternal and infant serum 25(OH)D concentrations correlated positively at baseline ( r = 0.36 , P = 0.01 ) and 3 months ( r = 0.46 , P = 0.002 ) . Milk antirachitic activity increased from undetectable ( < 20 IU L(-1 ) ) to a median of 50.9 IU L(-1 ) . In conclusion , combined maternal and infant vitamin D supplementation was associated with a threefold increase in infants ' serum 25(OH)D concentrations and a 64 % reduction in the prevalence of vitamin D deficiency without causing hypervitaminosis Background / Objective : To study whether a free supply of vitamin D2 drops to 6-week-old infants together with tailor-made information h and outs improves the vitamin D status after 7 weeks in the intervention group compared to a control group . Subjects/ Methods : In this cluster r and omized controlled trial in eight child health clinics in Oslo , Norway , 66 healthy infants with Pakistani , Turkish or Somali background were included . The intervention group received daily supplementation of vitamin D drops containing 10 μg ( 400 IU ) of ergocalciferol ( vitamin D2 ) with a tailor-made information brochure about vitamin D and its sources , and instruction on how to administer the drops . They were compared to a control group receiving usual care . The principal outcome measure was increase in serum 25-hydroxyvitamin D ( S-25OHD ) 7 weeks later . S-25OHD was analyzed by high-performance liquid chromatography-ultraviolet-mass spectrometry . Results : Total 78 % ( n=51 ) of the included infants completed the study . At follow-up , S-25OHD was significantly higher in the intervention group than in the control group ( 93.5 versus 72.7 nmol l−1 , P=0.03 ) . The mean increase in S-25OHD adjusted for baseline was 28 nmol l−1 ( 95 % confidence interval 10.9–45.2 , P=0.002 ) higher in the intervention group than in the control group . Among exclusively breastfed infants at baseline , S-25OHD increased by 32.3 nmol l−1 ( P=0.035 ) in the intervention group compared to control group . Conclusion : Free supply of vitamin D drops to 6-week-old infants together with tailor-made information h and outs significantly improved the vitamin D status of infants with immigrant background compared to usual care 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 is a pleiotropic hormone important for the recovery of organ systems after critical illness . Recent observational studies have suggested that three out of every four children are vitamin D deficient following cardiac surgery , with inadequate preoperative intake and surgical losses playing important contributory roles . Observed associations between postoperative levels , cardiovascular dysfunction and clinical course suggest that perioperative optimization of vitamin D status could improve outcome . With this two-arm , parallel , double blind , r and omized controlled trial ( RCT ) , we aim to compare immediate postoperative vitamin D status in children requiring cardiopulmonary bypass for congenital heart disease who receive preoperative daily high dose vitamin D supplementation ( high-dose arm ) with those who receive  usual intake ( low-dose arm ) . Methods / Design Eligibility requirements include age ( > 36 weeks , < 18 years ) and a congenital heart defect requiring cardiopulmonary bypass surgical correction . Enrollment of 62 participants will take place at a single Canadian tertiary care center over a period of 2 years . Children r and omized to the high-dose group will receive age-based dosing that was informed by the Institute of Medicine ( IOM ) daily tolerable upper intake level ( < 1 year old = 1,600 IU/day , > 1 year old = 2,400 IU/day ) . Children in the low-dose arm will receive usual care based on IOM recommendations ( < 1 year old = 400 IU , > 1 year old = 600 IU ) . The primary outcome measure is immediate postoperative vitamin D status , using blood 25(OH)D. Discussion Maintaining adequate postoperative vitamin D levels following surgery could represent an effective therapy to speed recovery following CHD surgery . The proposed research project will determine whether preoperative supplementation with a dosing regimen based on the IOM recommended daily upper tolerable intake will prevent postoperative vitamin-D deficiency in the majority of children . The results will then be used to inform the design of a large international RCT exploring whether preoperative optimization of vitamin D status might improve short and long-term outcomes in this vulnerable population .Trial Registration Clinical trials.gov Identifier - NCT01838447 Date of registration : 11 April Eighteen term , healthy , appropriate for gestational age , breast-fed infants were studied in a double-blind prospect i ve study to determine whether or not supplemental vitamin D affected bone mineralization .  All patients were from a single , private pediatric practice . Nine infants were r and omly assigned to a vitamin D supplement of 400 IU/day and nine infants to a placebo . By 12 weeks of age , infants receiving placebo had a significant decrease in bone mineralization and in serum 25-hydroxyvitamin D concentrations compared to the vitamin D-supplemented group . It is not known whether or not the increased BMC at 12 weeks of age in vitamin D-supplemented breast-fed infants is of ultimate value . Supplemental vitamin D may be necessary for optimal bone mineralization in term breast-fed infants . A longer follow-up study and additional analyses are required to make conclusive statements This study deals with the relationship between the occurrence of hypercalcemia and the administration of prophylactic doses of vitamin D in children with hypothyroidism , before and during L-thyroxine ( LT4 ) treatment .  The goal of the study was to determine the dosage of vitamin D necessary to prevent rickets without inducing hypercalcemia . There was a 23 % prevalence of hypercalcemia at the time of the diagnosis of hypothyroidism by screening whereas it was 21 % in the children who were not given vitamin D  during the first 3 months of LT4 treatment . This figure was significantly higher in those who were given vitamin D during the first 3 months of treatment and reached 70 % . However , one of the 19 children not given vitamin D presented with biological signs evoking vitamin D deficiency . In conclusion , in hypothyroid infants , vitamin D should be administered carefully during the first 6 months of treatment and restricted to children at risk for developing vitamin D deficiency Abstract Objective : The objective of this study was to evaluate the relationship between 25(OH)D , Vitamin D Binding Protein ( DBP ) , and free vitamin D in premature infants . Methods : Thirty-two infants < 32 weeks ’ gestation were r and omized to two different levels of vitamin D3 supplementation ( 400 vs. 800 IU/day ) . 25(OH)D levels were measured by LC-MS/MS ; DBP was measured by vali date d ELISA . Free vitamin D was calculated using molar ratios of 25(OH)D and DBP . The Wilcoxon signed rank test was used to compare DBP , free D and 25(OH)D levels ; Spearman ’s correlation coefficients were used to assess correlations . Results : The mean gestational age at birth was 30.5 weeks ; mean birth weight was 1405 g.  Mean 25(OH)D levels at birth were 17.3 ng/mL ; DBP levels were 297 mg/L , and estimated free vitamin D levels were 18.9 . There was a statistically significant change in 25(OH)D levels after 8 weeks ( 24.6 vs. 39.1 ng/mL in the 400 vs. 800 group , respectively , p=0.02 ) . DBP levels from birth to 8 weeks showed a statistically significant decrease ( 267 vs. 208 , p=0.04 ) . Estimated free 25(OH)D concentrations increased over the study period , from 18.9 at birth to 64.7 at 8 weeks of age ( p=0.0001 ) . Free vitamin D levels at birth were associated with global DEXA bone mineral content at discharge from the NICU ( r=0.58 , p=0.05 ) . Conclusion : Supplementation with vitamin D3 increased the free portion of the vitamin D metabolite , providing increased bioavailable substrate . Improved free vitamin D levels may improve measurable outcomes such as bone mineral content and deserve further evaluation • The recommended level for serum 25-hydroxyvitamin D ( 25(OH)D ) in infants , children , adolescents and during pregnancy and lactation is ≥ 50 nmol/L. This level may need to be 10 - 20 nmol/L higher at the end of summer to maintain levels ≥ 50 nmol/L over winter and spring . • Sunlight is the most important source of vitamin D. The US recommended dietary allowance for vitamin D is 600 IU daily in children aged over 12 months and during pregnancy and lactation , assuming minimal sun exposure . • Risk factors for low vitamin D are : lack of skin exposure to sunlight , dark skin , southerly latitude , conditions affecting vitamin D metabolism and storage ( including obesity ) and , for infants , being born to a mother with low vitamin D and exclusive breastfeeding combined with at least one other risk factor . • Targeted measurement of 25(OH)D levels is recommended for infants , children and adolescents with at least one risk factor for low vitamin D and for pregnant women with at least one risk factor for low vitamin D at the first antenatal visit . • Vitamin D deficiency can be treated with daily low-dose vitamin D supplements , although barriers to adherence have been identified . High-dose intermittent vitamin D can be used in children and adolescents . Treatment should be paired with health education and advice about sensible sun exposure . Infants at risk of low vitamin D should be supplemented with 400 IU vitamin D₃ daily for at least the first year of life . • There is increasing evidence of an association between low vitamin D and a range of non-bone health outcomes , however there is a lack of data from robust r and omised controlled trials of vitamin D supplementation Summary Background Vitamin D has a role in regulating immune function , and its deficiency is a suggested risk factor for childhood pneumonia . Our aim was to assess whether oral supplementation of vitamin D3 ( cholecalciferol ) will reduce the incidence and severity of pneumonia in a high-risk infant population . Methods We did a r and omised placebo-controlled trial to compare oral 100 000 IU ( 2·5 mg ) vitamin D3 with placebo given to children aged 1–11 months in Kabul , Afghanistan . R and omisation was by use of a computer-generated list . Vitamin D or placebo was given by fieldworkers once every 3 months for 18 months . Children presenting at the study hospital with signs of pneumonia had their diagnosis confirmed radiographically . Our primary outcome was the first or only episode of radiologically confirmed pneumonia . Our analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00548379 . Findings 1524 children were assigned to receive vitamin D3 and 1522 placebo .  There was no significant difference between the incidence of first or only pneumonia between the vitamin D ( 0·145 per child per year , 95 % CI 0·129–0·164 ) and the placebo group ( 0.137 , 0·121–0·155 ) ; the incidence rate ratio was 1·06 ( 95 % CI 0·89–1·27 ) . From 652 children during five separate periods of testing serum calcifediol , only one child in each of two testing periods had results greater than 375 nmol/L in the intervention group — a toxic level . Interpretations Quarterly bolus doses of oral vitamin D3 supplementation to infants are not an effective intervention to reduce the incidence of pneumonia in infants in this setting . Funding Wellcome Trust and British Council Background Vitamin 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. ‘ st and ard 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 / Design This study is a pragmatic r and omized 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 r and omized to the ‘ st and ard 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 . Discussion Identifying 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
They do not provide any additional evidence that larger , more generous amounts of daily vitamin D beyond the customary recommended 400 IU daily dose , affect any significant outcome .
Larger amounts may lead to serum 25 hydroxy vitamin D concentrations that have been reported to be potentially associated with adverse effects .
Summary There are still many unanswered questions left , in particular whether or not more ‘ generous ’ amounts of vitamin D in infancy may improve long-term health outcomes such as prevention of osteoporosis , allergies , or cancer
Purpose of review New evidence for recommendations for vitamin D supplementation in healthy infants based upon recent literature .