Participant Flow Diagram
LGA
RECRUITMENT
Participant flow diagram showing number of mother-infant dyads assessed for eligibility 24 to 36 hours after delivery, enrolled to newborn screening, screened, enrolled to the postnatal study, and allocated to either the trial group (serum 25-hydroxyvitamin D (25[OH]D) concentrations less than 50 nmol/L [ie, 20 ng/mL]) or reference group (serum 25[OH]D concentrations of 50 nmol/L or more). Infants allocated to the trial group were randomized to receive either 400 or 1000 IU per day. Infants in the reference group received 400 IU per day. Sample size per group at each time point reflects the number analyzed for biomarkers and the number of whole-body (WB) and lumbar spine (LS) scans available at each study visit are reported. LGA indicates large for gestational age; SGA, small for gestational age.Ethical approval was obtained from St. Mary’s Hospital Research Ethics Committee, which oversees research ethics for the Lakeshore General Hospital (SMHC-15-34), where newborn recruitment took place. The study was also reviewed and approved by Health Canada Research Ethics Board (REB 2019-033H) and Privacy Management Division (HC-PR-2019-000024). Written consent was obtained from the parents at the newborn screening and the baseline visit. The trial was conducted at the Mary Emily Clinical Nutrition Research Unit, McGill University, Sainte-Anne-de-Bellevue, Quebec, Canada.