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Effect of micronutrient supplement on health and nutritional status of schoolchildren : study design . OBJECTIVE We tested the hypothesis that supplementation with a micronutrient-fortified beverage improves micronutrient status and physical and mental development in apparently healthy schoolchildren . METHODS The study was carried out in middle-income students in two residential schools that catered to children from a semi-urban population near Hyderabad , India . Included were 869 children who were 6 to 16 y of age in grades 1 to 10 . Because children at each grade were distributed across two classrooms ( clusters ) and were homogeneous , each grade was considered to consist of a matched pair . There were thus 10 pairs available for the study . Classes in each grade were randomized to receive a micronutrient-enriched beverage or a placebo without added micronutrients . The study was double blinded and the duration was 14 mo , with supervised feeding of the micronutrient-enriched beverage . The effect of the micronutrients on the outcome variables growth , biochemical status , mental function , and bone health were assessed . RESULTS The number of matched pairs varied between seven and eight , and the required number of children per treatment group ranged from 32 in the case of bone heath to 177 for body weight . The power of the outcome variables ranged from 74 % to 100 % and was adequate for successful pairing . The effect assessed at the end of supplementation showed that the intervention was beneficial . CONCLUSIONS Designing an intervention , choosing outcome variables , and implementing the protocol in a typical Indian school setting were achieved .
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Intervention_Pharmacological
micronutrient supplement
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Intervention_Pharmacological
micronutrient-fortified beverage
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Intervention_Pharmacological
micronutrient-enriched beverage
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Intervention_Control
placebo without added micronutrients
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Intervention_Pharmacological
micronutrient-enriched beverage
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Intervention_Pharmacological
micronutrients
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Intervention_Pharmacological
supplementation
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Outcome_Physical
health and nutritional status
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Outcome_Physical
outcome variables growth , biochemical status
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Outcome_Mental
mental function
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Outcome_Physical
bone health
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Outcome_Other
beneficial