Can correction of low vitamin D status in infancy program for a leaner body composition?: a post-trial follow-up study of whole body lean mass in early childhood.

Vitamin D supplementation is recommended for infants fed human milk and may have a role in supporting the development of lean body mass. The main objective was to explore if the effects of 1000 IU/d compared to 400 IU/d of vitamin D3 (cholecalciferol) supplementation in infancy (1-12 months) on lean body mass were maintained post-trial, up to 36 months of age. This post-trial follow-up study of a vitamin D supplementation trial (98 infants from 1 to 12 months of age in Montréal) included 49 children at 24 months (400 IU/d: n=21, 1000 IU/d: n=28) until early study closure; the COVID-19 pandemic precluded reporting at 36 months and completion of a non-randomized reference group. The primary outcome was whole body lean mass (dual-energy x-ray absorptiometry). Other outcomes included: serum 25-hydroxyvitamin D 25(OH)D (immunoassay), and measures of anthropometry, and whole body fat mass and bone mineral content (BMC). Developmental milestones were added at 24 months (Ages and Stages Questionnaire-3). Data were analyzed using linear mixed-effects regression with random intercepts; differences post-trial were tested if the treatment x time interaction was significant. At 24 months whole body lean mass (difference: 538.5 g, 95%CI: 44.2, 1032.8 g, P=0.033), BMC (difference: 25.08 g, 95%CI: 2.59, 47.56, P=0.029), weight (difference: 0.90 kg, 95%CI: 0.17, 1.63, P=0.016) and length (difference: 2.4 cm, 95%CI: 0.9, 4.0, P= 0.002) were greater in the 1000 IU/d group than the 400 IU/d group. Serum 25(OH)D concentrations, fat mass and developmental milestones were not significantly different between groups. The greater whole body lean mass observed in infants in our published trial of 1000 IU/d of vitamin D supplementation compared to 400 IU/d was maintained post-trial at 24 months in accordance with greater length. Confirmation of these observations, and whether these extend into later childhood, requires new trials. NCT02563015. Registered 28 September 2015. https://www. gov/study/NCT02563015.