Effect of Different Dosages of Oral Vitamin D Supplementation on Vitamin D Status in Healthy, Breastfed Infants: A Randomized Trial

摘要: Importance Vitamin D supplementation in infancy is required to support healthy bone mineral accretion. A supplement of 400 IU vitamin per day thought plasma 25-hydroxyvitamin (25[OH]D) concentrations between 40 and 50 nmol/L; some advocate 75 150 nmol/L for health. Objective To investigate the efficacy different dosages supporting 25(OH)D infants. Design, Setting, Participants Double-blind randomized clinical trial conducted among 132 one-month-old healthy, term, breastfed infants from Montreal, Quebec, Canada, March 2007 August 2010. Infants were followed up 11 months ending 2011 (74% completed study). Intervention randomly assigned receive oral cholecalciferol (vitamin 3 ) supplements IU/d (n=39), 800 1200 (n=38), or 1600 (n=16). Main Outcomes Measures The primary outcome was a concentration greater 97.5% at months. Secondary outcomes included 6, 9, 12 months; across all times; growth; whole body regional content. Data analyzed by intention treat using available data, logistic regression, mixed-model analysis variance. Results By months, 55% (95% CI, 38%-72%) 400-IU/d group achieved vs 81%(95% 65%-91%) 800-IU/d group, 92% 77%-98%) 1200-IU/d 100% 1600-IU/d group. This not sustained any groups. dosage discontinued prematurely because elevated concentrations. All established 97% 94%-100%) this 98% Growth content did differ dosage. Conclusions Relevance Among infants, only (but 400, 800, IU/d) increased However, levels that have been associated with hypercalcemia. Trial Registration clinicaltrials.gov Identifier: NCT00381914