Impact of Fortified Malt-Based Food on Immunity Outcomes in School Children in India: Cluster Randomized Controlled Trial
Abstract BackgroundNutritional inadequacy and consequent diminished immunity among school-age children is a public health problem in India. Nutrition interventional studies using a cluster randomized controlled trial (RCT) design can avoid ethical issues inherent in double-bli...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2025-06-01
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| Series: | Interactive Journal of Medical Research |
| Online Access: | https://www.i-jmr.org/2025/1/e54189 |
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| Summary: | Abstract
BackgroundNutritional inadequacy and consequent diminished immunity among school-age children is a public health problem in India. Nutrition interventional studies using a cluster randomized controlled trial (RCT) design can avoid ethical issues inherent in double-blind individual RCTs in children involving daily administration of an empty-calorie placebo.
ObjectiveWe tested the hypothesis that daily administration of a fortified malt-based food (FMBF), a multinutrient supplement, would improve immunity outcomes against common infectious diseases, nutritional status, and gut health in Indian school-age children by using a cluster RCT design. This report presents the study design attributes and the baseline characteristics of the study population.
MethodsThis was an open-label, 2-arm, parallel-group, matched-pair cluster RCT, stratified by gender, in children aged ≥7 to ≤10 years old with height-for-age z
ResultsObserved mean age (SD) was 8.0 (SD 0.81; range: 7-10) years. There was no significant difference in mean age (PPPPPP
ConclusionsThe findings highlight the extent of nutritional inadequacies in Indian school-age children, reaffirming the need for nutritional strategies to optimize the nutritional status among these children. A cluster RCT design can be effectively used in nutritional intervention trials with children by maintaining high compliance and retention. |
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| ISSN: | 1929-073X |