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

Reliability of routinely collected anthropometric measurements in primary care

Abstract Background Measuring body mass index (BMI) has been proposed as a method of screening for preventive primary care and population surveillance of childhood obesity. However, the accuracy of routinely collected measurements has been questioned. The purpose of this study was to assess the reliability of height, length and weight measurements collected during well-child visits in primary care relative to trained research personnel. Methods A cross-sectional study of measurement reliability was conducted in community pediatric and family medicine primary care practices. Each participating child, ages 0 to 18 years, was measured four consecutive times; twice by a primary care team member (e.g. nurses, practice personnel) and twice by a trained research assistant. Inter- and intra-observer reliability was calculated using the technical error of measurement (TEM), relative TEM (%TEM), and a coefficient of reliability (R). Results Six trained research assistants and 16 primary care team members performed measurements in three practices. All %TEM values for intra-observer reliability of length, height, and weight were classified as ‘acceptable’ ( 99% for both intra- and inter-observer reliability. Length measurements in children < 2 years had the highest measurement error. There were some significant differences in length intra-observer reliability between observers. Conclusion There was agreement between routine measurements and research measurements although there were some differences in length measurement reliability between practice staff and research assistants. These results provide justification for using routinely collected data from selected primary care practices for secondary purposes such as BMI population surveillance and research

The Association between Early Childhood and Later Childhood Sugar-Containing Beverage Intake: A Prospective Cohort Study

Sugar-containing beverages (SCBs) are a major source of sugar intake in children. Early life intake of SCBs may be a strong predictor of SCB intake later in life. The primary objective of this study was to evaluate if SCB intake (defined as 100% fruit juice, soda, and sweetened drinks) in early childhood (&le;2.5 years of age) was associated with SCB intake in later childhood (5&ndash;9 years of age). A prospective cohort study was conducted using data from the TARGet Kids! primary care practice network (n = 999). Typical daily SCB intake was measured by parent-completed questionnaires. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using logistic regression. A total of 43% of children consumed &ge;0.5 cups/day of SCBs at &le;2.5 years and this increased to 64% by 5&ndash;9 years. Daily SCB intake, compared to no daily intake, at &le;2.5 years was significantly associated with SCB intake at 5&ndash;9 years (adjusted OR: 4.03; 95% CI: 2.92&ndash;5.55) and this association was much stronger for soda/sweetened drinks (adjusted OR: 12.83; 95% CI: 4.98, 33.0) than 100% fruit juice (OR: 3.61; 95% CI: 2.63&ndash;4.95). Other early life risk factors for SCB intake at 5&ndash;9 years were presence of older siblings, low household income, and shorter breastfeeding duration. Daily intake of SCBs in early childhood was strongly associated with greater SCB intake in later childhood. Early life may be an important period to target for population prevention strategies

Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children.

ImportanceEpidemiological 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.ObjectiveTo 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 participantsA 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.InterventionsThree 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 measuresThe 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.ResultsAmong 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 relevanceAmong 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 registrationclinicaltrials.gov Identifier: NCT01419262

Automated Self-Administered 24-H Dietary Assessment Tool (ASA24) recalls for parent proxy-reporting of children’s intake (> 4 years of age): a feasibility study

Abstract Background Robust measurement of dietary intake in population studies of children is critical to better understand the diet–health nexus. It is unknown whether parent proxy-report of children’s dietary intake through online 24-h recalls is feasible in large cohort studies. Objectives The primary objective of this study was to describe the feasibility of the Automated Self-Administered 24-h Dietary Assessment Tool (ASA24) to measure parent proxy-reported child dietary intake. A secondary objective was to compare intake estimates with those from national surveillance. Methods Parents of children aged 4–15 years participating in the TARGet Kids! research network in Toronto, Canada were invited by email to complete an online ASA24-Canada-2016 recall for their child, with a subsample prompted to complete a second recall about 2 weeks later. Descriptive statistics were reported for ASA24 completion characteristics and intake of several nutrients. Comparisons were made to the 2015 Canadian Community Health Survey (CCHS) 24-h recall data. Results A total of 163 parents completed the first recall, and 46 completed the second, reflecting response rates of 35% and 59%, respectively. Seven (4%) first recalls and one (2%) second recall were excluded for ineligibility, missing data, or inadvertent parental self-report. The median number of foods reported on the first recall was 18.0 (interquartile range (IQR) 6.0) and median time to complete was 29.5 min (IQR 17.0). Nutrient intakes for energy, total fat, protein, carbohydrates, fiber, sodium, total sugars, and added sugars were similar across the two recalls and the CCHS. Conclusions The ASA24 was found to be feasible for parent proxy-reporting of children’s intake and to yield intake estimates comparable to those from national surveillance, but strategies are needed to increase response rate and support completion to enhance generalizability

Xylitol for the prevention of acute otitis media episodes in children aged 2-4 years: protocol for a pragmatic randomised controlled trial.

IntroductionXylitol (or 'birch sugar') is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute otitis media (AOM), a common and costly condition in young children. The primary outcome will be the incidence of AOM. Secondary outcomes will include upper respiratory tract infections (URTIs) and dental caries.Methods and analysisThis study will be a pragmatic, blinded (participant and parents, practitioners and analyst), two-armed superiority, placebo-controlled randomised trial with 1:1 allocation, stratified by clinical site. The trial will be conducted in the 11 primary care group practices participating in the TARGet Kids! research network in Canada. Eligible participants between the ages of 2-4 years will be randomly assigned to the intervention arm of regular xylitol syrup use or the control arm of regular sorbitol use for 6 months. We expect to recruit 236 participants, per treatment arm, to detect a 20% relative risk reduction in AOM episodes. AOM will be identified through chart review. The secondary outcomes of URTIs and dental caries will be identified through monthly phone calls with specified questions.Ethics and disseminationEthics approval from the Research Ethics Boards at the Hospital for Sick Children and St. Michael's Hospital has been obtained for this study and also for the TARGet Kids! research network. Results will be submitted for publication to a peer-reviewed journal and will be discussed with decision makers.Trial registration numberNCT03055091; Pre-results

Late preterm birth and growth trajectories during childhood: a linked retrospective cohort study

Abstract Background Evidence suggests that accelerated postnatal growth in children is detrimental for adult cardiovascular health. It is unclear whether children born late preterm (34–36 weeks) compared to full term (≥ 39 weeks), have different growth trajectories. Our objective was to evaluate the association between gestational age groups and growth trajectories of children born between 2006–2014 and followed to 2021 in Ontario, Canada. Methods We conducted a retrospective cohort study of children from singleton births in TARGet Kids! primary care network with repeated measures of weight and height/length from birth to 14 years, who were linked to health administrative databases. Piecewise linear mixed models were used to model weight (kg/month) and height (cm/month) trajectories with knots at 3, 12, and 84 months. Analyses were conducted based on chronological age. Results There were 4423 children included with a mean of 11 weight and height measures per child. The mean age at the last visit was 5.9 years (Standard Deviation: 3.1). Generally, the more preterm, the lower the mean value of weight and height until early adolescence. Differences in mean weight and height for very/moderate preterm and late preterm compared to full term were evident until 12 months of age. Weight trajectories were similar between children born late preterm and full term with small differences from 84–168 months (mean difference (MD) -0.04 kg/month, 95% CI -0.06, -0.03). Children born late preterm had faster height gain from 0–3 months (MD 0.70 cm/month, 95% CI 0.42, 0.97) and 3–12 months (MD 0.17 cm/month, 95% CI 0.11, 0.22). Conclusions Compared to full term, children born late preterm had lower average weight and height from birth to 14 years, had a slightly slower rate of weight gain after 84 months and a faster rate of height gain from 0–12 months. Follow-up is needed to determine if growth differences are associated with long-term disease risk