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.