We did a randomised placebo-controlled trial to compare oral 100鈥?00 IU (2路5 mg) vitamin D3 with placebo given to children aged 1-11 months in Kabul, Afghanistan. Randomisation was by use of a computer-generated list. Vitamin D or placebo was given by fieldworkers once every 3 months for 18 months. Children presenting at the study hospital with signs of pneumonia had their diagnosis confirmed radiographically. Our primary outcome was the first or only episode of radiologically confirmed pneumonia. Our analysis was by intention to treat. This study is registered with , number .
1524 children were assigned to receive vitamin D3 and 1522 placebo. There was no significant difference between the incidence of first or only pneumonia between the vitamin D (0路145 per child per year, 95%CI 0路129-0路164) and the placebo group (0.137, 0路121-0路155); the incidence rate ratio was 1路06 (95%CI 0路89-1路27). From 652 children during five separate periods of testing serum calcifediol, only one child in each of two testing periods had results greater than 375 nmol/L in the intervention group鈥攁 toxic level.
Quarterly bolus doses of oral vitamin D3 supplementation to infants are not an effective intervention to reduce the incidence of pneumonia in infants in this setting.
Wellcome Trust and British Council.