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Background: Observational studies support the role of vitamin D in reducing viral upper respiratory tract infection (URTI) symptom severity in adults and children. This study assessed whether wintertime high-dose vitamin D supplementation (2000 IU/day) reduces URTI symptom severity compared with standard-dose (400 IU/day) supplementation in preschool children. Secondary objectives were to assess effects of high-dose supplementation on outpatient physician visits, emergency department (ED) visits and antibiotic prescriptions for URTI., Methods: This was a secondary analysis of a multisite randomized clinical trial involving 703 healthy 1- to 5-year-old children in Toronto, Canada. High-dose or standard-dose oral vitamin D was randomly assigned for 1 winter season. For each URTI, parents completed symptom checklists based on the Canadian Acute Respiratory and Flu Scale. Symptom severity, frequency of outpatient visits, ED visits and antibiotic prescriptions for URTI between groups were analyzed using negative binomial regression., Results: URTI symptom severity was not reduced in the high-dose vs. standard-dose group [incidence rate ratio (IRR) = 0.97; 95% confidence interval (CI): 0.76-1.23]. High-dose vitamin D did not decrease frequency of outpatient visits (IRR = 1.16; 95% CI: 0.84-1.60), ED visits (IRR = 1.17; 95% CI: 0.57-2.40) or antibiotic prescriptions (IRR=1.02; 95% CI: 0.61-1.72). Serum 25-hydroxyvitamin D was higher in the high-dose group (48.7 ng/mL; 95% CI: 46.9-50.5) than the standard-dose group (36.8 ng/mL; 95% CI: 35.4-38.2; P < 0.001)., Conclusions: High-dose vitamin D supplementation did not reduce URTI symptom severity, outpatient visits, ED visits or antibiotic prescriptions relative to standard-dose. These results do not support vitamin D supplementation above the standard recommended dose for reducing URTI symptoms in children.

Importance: Epidemiological studies support a link between low 25-hydroxyvitamin D levels and a higher risk of viral upper respiratory tract infections. However, whether winter supplementation of vitamin D reduces the risk among children is unknown., Objective: To determine whether high-dose vs standard-dose vitamin D supplementation reduces the incidence of wintertime upper respiratory tract infections in young children., Design, Setting, and Participants: A randomized clinical trial was conducted during the winter months between September 13, 2011, and June 30, 2015, among children aged 1 through 5 years enrolled in TARGet Kids!, a multisite primary care practice-based research network in Toronto, Ontario, Canada., Interventions: Three hundred forty-nine participants were randomized to receive 2000 IU/d of vitamin D oral supplementation (high-dose group) vs 354 participants who were randomized to receive 400 IU/d (standard-dose group) for a minimum of 4 months between September and May., Main Outcome Measures: The primary outcome was the number of laboratory-confirmed viral upper respiratory tract infections based on parent-collected nasal swabs over the winter months. Secondary outcomes included the number of influenza infections, noninfluenza infections, parent-reported upper respiratory tract illnesses, time to first upper respiratory tract infection, and serum 25-hydroxyvitamin D levels at study termination., Results: Among 703 participants who were randomized (mean age, 2.7 years, 57.7% boys), 699 (99.4%) completed the trial. The mean number of laboratory-confirmed upper respiratory tract infections per child was 1.05 (95% CI, 0.91-1.19) for the high-dose group and 1.03 (95% CI, 0.90-1.16) for the standard-dose group, for a between-group difference of 0.02 (95% CI, -0.17 to 0.21) per child. There was no statistically significant difference in number of laboratory-confirmed infections between groups (incidence rate ratio [RR], 0.97; 95% CI, 0.80-1.16). There was also no significant difference in the median time to the first laboratory-confirmed infection: 3.95 months (95% CI, 3.02-5.95 months) for the high-dose group vs 3.29 months (95% CI, 2.66-4.14 months) for the standard-dose group, or number of parent-reported upper respiratory tract illnesses between groups (625 for high-dose vs 600 for standard-dose groups, incidence RR, 1.01; 95% CI, 0.88-1.16). At study termination, serum 25-hydroxyvitamin D levels were 48.7 ng/mL (95% CI, 46.9-50.5 ng/mL) in the high-dose group and 36.8 ng/mL (95% CI, 35.4-38.2 ng/mL) in the standard-dose group., Conclusions and Relevance: Among healthy children aged 1 to 5 years, daily administration of 2000 IU compared with 400 IU of vitamin D supplementation did not reduce overall wintertime upper respiratory tract infections. These findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infections., Trial Registration: clinicaltrials.gov Identifier: NCT01419262.

Objective: Upper respiratory tract infections (URTI) are the most common and costly condition of childhood. Low vitamin D levels have been hypothesized as a risk factor for URTI. The primary objective was to determine if serum vitamin D levels were associated with health-service utilization (HSU) for URTI including hospital admission, emergency department visits and outpatient sick visits. The secondary objectives were to determine whether oral vitamin D supplementation in pregnancy or childhood was associated with HSU for URTI., Design: Cohort study. HSU was determined by linking each child's provincial health insurance number to health administrative databases. Multivariable quasi Poisson regression was used to evaluate the association between 25-hydroxyvitamin D, vitamin D supplementation and HSU for URTI., Setting: Toronto, Canada., Subjects: Children participating in the TARGet Kids! network between 2008 and 2013., Results: Healthy children aged 0-5 years (n 4962) were included; 52 % were male and mean 25-hydroxyvitamin D was 84 nmol/l (range 11-355 nmol/l). There were 105 (2 %), 721 (15 %) and 3218 (65 %) children with at least one hospital admission, emergency department visit or outpatient sick visit for URTI, respectively. There were no statistically significant associations between 25-hydroxyvitamin D or vitamin D supplementation and HSU for URTI., Conclusions: A clinically meaningful association between vitamin D (continuously and dichotomized at <50 and <75 nmol/l) and HSU for URTI was not identified. While vitamin D may have other benefits for health, reducing HSU for URTI does not appear to be one of them.

The objective of this study was to evaluate the association of vitamin D intake and serum levels with fracture risk in children under 6 years of age. A case-control study was conducted in Toronto, Ontario, Canada. Cases were recruited from the fracture clinic at the Hospital for Sick Children, and matched controls were obtained from the TARGet Kids! primary-care research network. Controls were matched to cases on age, sex, height, and season. Fracture risk was estimated from conditional logistic regression, with adjustment for skin type, fracture history, waist circumference, outdoor free play, neighborhood income, soda consumption, and child's birth weight. A total of 206 cases were recruited during May 2009-April 2013 and matched to 343 controls. Serum 25-hydroxyvitamin D concentration (per 10-nmol/L increment: adjusted odds ratio (aOR) = 0.95, 95% confidence interval (CI): 0.88, 1.03) and intake of cow's milk (<2 cups/day vs. 2 cups/day: aOR = 0.95 (95% CI: 0.60, 1.52); >2 cups/day vs. 2 cups/day: aOR = 1.39 (95% CI: 0.85, 2.23)) were not significantly associated with reduced odds of fracture. A statistically significant association was observed between child use of vitamin D supplements and decreased odds of fracture (yes vs. no: aOR = 0.42, 95% CI: 0.25, 0.69). Vitamin D supplementation, but not serum 25-hydroxyvitamin D level or milk intake, was associated with reduced fracture risk among these healthy young children., (© The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: To determine the association between total breastfeeding duration and serum 25-hydroxyvitamin D (25-OHD) and to explore whether vitamin D supplementation influences this association., Methods: We conducted a cross-sectional study of healthy children between September 2011 and August 2013 through the TARGet Kids! primary health care research network. Of the 4533 eligible children, we included only the 2508 who had 25-OHD measured. We assessed adjusted associations of total breastfeeding duration (in months) with serum 25-OHD and in supplemented versus nonsupplemented children, with the odds of 25-OHD less than 20 nanograms per milliliter., Results: Each 1-month increase in total breastfeeding duration was associated with a 0.12 nanograms per milliliter lower median serum 25-OHD (95% confidence interval [CI] = -0.21 ng/mL, -0.02 ng/mL) among children who were not supplemented. The odds of serum 25-OHD less than 20 nanograms per milliliter increased by 6% (odds ratio [OR] = 1.06; 95% CI = 1.03, 1.10) for every 1-month increase in total breastfeeding duration among nonsupplemented children. The interaction between vitamin D supplementation, duration of breastfeeding, and median serum 25-OHD was statistically significant (P = .04)., Conclusions: Breastfed children who were not supplemented, particularly those breastfed more than 1 year, appear to have lower vitamin D status. Vitamin D supplementation may mitigate this risk. These findings support recommendations for supplementation during breastfeeding of any duration.

Background: The OptEC trial aims to evaluate the effectiveness of oral iron in young children with non-anemic iron deficiency (NAID). The initial sample size calculated for the OptEC trial ranged from 112-198 subjects. Given the uncertainty regarding the parameters used to calculate the sample, an internal pilot study was conducted. The objectives of this internal pilot study were to obtain reliable estimate of parameters (standard deviation and design factor) to recalculate the sample size and to assess the adherence rate and reasons for non-adherence in children enrolled in the pilot study., Methods: The first 30 subjects enrolled into the OptEC trial constituted the internal pilot study. The primary outcome of the OptEC trial is the Early Learning Composite (ELC). For estimation of the SD of the ELC, descriptive statistics of the 4 month follow-up ELC scores were assessed within each intervention group. The observed SD within each group was then pooled to obtain an estimated SD (S2) of the ELC. Correlation (ρ) between the ELC measured at baseline and follow-up was assessed. Recalculation of the sample size was performed using analysis of covariance (ANCOVA) method which uses the design factor (1- ρ(2)). Adherence rate was calculated using a parent reported rate of missed doses of the study intervention., Conclusion: The new estimate of the SD of the ELC was found to be 17.40 (S2). The design factor was (1- ρ2) = 0.21. Using a significance level of 5%, power of 80%, S2 = 17.40 and effect estimate (Δ) ranging from 6-8 points, the new sample size based on ANCOVA method ranged from 32-56 subjects (16-28 per group). Adherence ranged between 14% and 100% with 44% of the children having an adherence rate ≥ 86%. Information generated from our internal pilot study was used to update the design of the full and definitive trial, including recalculation of sample size, determination of the adequacy of adherence, and application of strategies to improve adherence., Trial Registration: ClinicalTrials.gov Identifier: NCT01481766 (date of registration: November 22, 2011).

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. '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/design: This 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., 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.

OBJECTIVES To determine the effect of modifiable dietary intake variables (current vitamin D supplementation and daily cow's milk intake) on 25-hydroxyvitamin D level in early childhood and to evaluate the relationship between these modifiable dietary factors and other largely nonmodifiable determinants of vitamin D status including skin pigmentation and season. DESIGN Cross-sectional study. SETTING Primary care pediatric and family medicine practices participating in the TARGet Kids! practice-based research network in Toronto, Ontario, Canada. PARTICIPANTS From December 2008 to June 2011, healthy children 1 to 5 years of age were recruited during a routine physician's visit. INTERVENTIONS Survey, anthropometric measurements, and laboratory data were collected. A multivariable linear regression model was developed to examine the independent effects of vitamin D supplementation and daily volume of cow's milk on 25-hydroxyvitamin D level. MAIN OUTCOME MEASURES 25-Hydroxyvitamin D level. RESULTS Blood was obtained in 1898 children. Two modifiable dietary intake variables, vitamin D supplementation and cow's milk, increased 25-hydroxyvitamin D level by 3.4 ng/mL (95% CI, 2-4 ng/mL) and 1.6 ng/mL per 250-mL cup per day (95% CI, 1-2 ng/mL), respectively. Two nonmodifiable variables reflecting cutaneous vitamin D synthesis (skin pigmentation and season) were also strongly associated with 25-hydroxyvitamin D status but accounted for a much smaller proportion of the explained variation in 25-hydroxyvitamin D level. The effect of vitamin D supplementation and milk intake on 25-hydroxyvitamin D level appeared similar regardless of skin pigmentation or season. CONCLUSION Two modifiable dietary intake variables (vitamin D supplementation and cow's milk intake) are the most important determinants of 25-hydroxyvitamin D status in early childhood.

Several studies have suggested an association between vitamin D in childhood and autism spectrum disorder. No prospective studies have evaluated whether lower vitamin D levels precede ASD diagnoses – a necessary condition for causality. The objective of this study was to prospectively evaluate whether vitamin D serum levels in early childhood was associated with incident physician diagnosed ASD. A prospective cohort study was conducted using data from preschool-aged children in the TARGet Kids! practice-based research network in Toronto, Canada, from June 2008 to July 2015. 25-hydroxyvitamin D concentration was measured through blood samples and vitamin D supplementation from parent report. Autism spectrum disorder diagnosis was determined from medical records at follow-up visits. Covariates included age, sex, family history of autism spectrum disorder, maternal ethnicity, and neighborhood household income. Unadjusted and adjusted relative risks and 95% confidence intervals were estimated using Poisson regression with a robust error variance. In this study, 3852 children were included. Autism spectrum disorder diagnosis was identified in 41 children (incidence = 1.1%) over the observation period (average follow-up time = 2.5 years). An association between 25-hydroxyvitamin D concentration and autism spectrum disorder was not identified in the unadjusted (relative risk = 1.04, 95% confidence interval: 0.97, 1.11 per 10 nmol/L increase in 25-hydroxyvitamin D concentration) or adjusted models (adjusted relative risk = 1.06; 95% confidence interval: 0.95, 1.18). An association between vitamin D supplementation in early childhood and autism spectrum disorder was also not identified (adjusted relative risk = 0.86, 95% confidence interval: 0.46, 1.62). Vitamin D in early childhood may not be associated with incident physician diagnoses of autism spectrum disorder. [ABSTRACT FROM AUTHOR]