Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial.

BACKGROUND: More than a third of the world's children are infected with intestinal nematodes. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool children. METHODOLOGY: We studied the effects on the heights and weights of 3,935 children, initially 1 to 5 years of age, of five rounds of anthelmintic treatment (400 mg albendazole) administered every 6 months over 2 years. The children lived in 50 areas, each defined by precise government boundaries as urban slums, in Lucknow, North India. All children were offered vitamin A every 6 months, and children in 25 randomly assigned slum areas also received 6-monthly albendazole. Treatments were delivered by the State Integrated Child Development Scheme (ICDS), and height and weight were monitored at baseline and every 6 months for 24 months (trial registration number NCT00396500). p Value calculations are based only on the 50 area-specific mean values, as randomization was by area. FINDINGS: The ICDS infrastructure proved able to deliver the interventions. 95% (3,712/3,912) of those alive at the end of the study had received all five interventions and had been measured during all four follow-up surveys, and 99% (3,855/3,912) were measured at the last of these surveys. At this final follow up, the albendazole-treated arm exhibited a similar height gain but a 35 (SE 5) % greater weight gain, equivalent to an extra 1 (SE 0.15) kg over 2 years (99% CI 0.6-1.4 kg, p = 10(-11)). CONCLUSIONS: In such urban slums in the 1990s, five 6-monthly rounds of single dose anthelmintic treatment of malnourished, poor children initially aged 1-5 years results in substantial weight gain. The ICDS system could provide a sustainable, inexpensive approach to the delivery of anthelmintics or micronutrient supplements to such populations. As, however, we do not know the control parasite burden, these results are difficult to generalize. TRIAL REGISTRATION: ClinicalTrials.gov NCT00396500.