Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial.

objectiveTo evaluate the efficacy of milk fortified with specific multiple micronutrients on morbidity in children compared with the same milk without fortification.

designCommunity based, double masked, individually randomised trial.

settingPeri-urban settlement in north India.

participantsChildren (n=633) aged 1-3 randomly allocated to receive fortified milk (n=316) or control milk (n=317).

interventionOne year of fortified milk providing additional 7.8 mg zinc, 9.6 mg iron, 4.2 microg selenium, 0.27 mg copper, 156 microg vitamin A, 40.2 mg vitamin C, 7.5 mg vitamin E per day (three feeds).

main outcome measuresDays with severe illnesses, incidence and prevalence of diarrhoea, and acute lower respiratory illness.

resultsStudy groups were comparable at baseline; compliance in the groups was similar. Mean number of episodes of diarrhoea per child was 4.46 (SD 3.8) in the intervention (fortified milk) group and 5.36 (SD 4.1) in the control group. Mean number of episodes of acute lower respiratory illness was 0.62 (SD 1.1) and 0.83 (SD 1.4), respectively. The fortified milk reduced the odds for days with severe illnesses by 15% (95% confidence interval 5% to 24%), the incidence of diarrhoea by 18% (7% to 27%), and the incidence of acute lower respiratory illness by 26% (3% to 43%). Consistently greater beneficial effects were observed in children aged < or =24 months than in older children.

conclusionMilk is well accepted as a means of delivery of micronutrients. Consumption of milk fortified with specific micronutrients can significantly reduce the burden of common morbidities among preschool children, especially in the first two years of life.

trial registrationNCT00255385 [ClinicalTrials.gov].