Late Breaking Abstract - Effect of supplementation with vitamin D on acute bronchitis prevention during the first year of life

Background: Epidemiologic data suggest a role of low vitamin D levels in respiratory tract infections in infants. Objectives: To determine whether high dose (1,000 IU/d) vs standard dose vitamin D supplementation reduces the proportion of infants with acute bronchitis during the first year of life. Secondary outcomes were reduction of infants with recurrent bronchitis, hospitalizations for acute bronchiolitis and upper respiratory tract infections (URTI), and the achievement of a higher percentage of children with adequate vitamin D blood levels. Methods: Phase III multicentre randomized double blind clinical trial. Healthy full-term Infants were randomized to receive either 400 IU or 1,000 IU/d of vitamin D up to 1 year of age. Results: 198 children were included, 94 in the 400 IU group and 104 in the 1000 IU group. There were no differences in the percentage of children who presented acute bronchitis, recurrent bronchitis, URTI, or were admitted due to bronchiolitis. At birth, 72.7% of the children had severe or moderate vitamin D deficiency. A higher percentage of children achieved vitamin D levels u003e 30 ng/ml in the 1,000 IU/day group (75% vs 55.9%). The profile of adverse effects was similar in both groups. Conclusions: Although it was safe and resulted in higher vitamin D levels, daily administration of 1,000 IU of vitamin D, compared to 400 IU, did not decrease acute or recurrent bronchitis or URTI in infants. Supported by a grant from Spanish Ministry of Health (EC11-476)