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. 2025 Jun 25:14:e54189.
doi: 10.2196/54189.

Impact of Fortified Malt-Based Food on Immunity Outcomes in School Children in India: Cluster Randomized Controlled Trial

Anuradha Khadilkar  1 , Vinay Rawat  2 , Jaladhi Bhatt  3 , Devyani Chaturvedi  4 , Vivek Garg  2 , Pankaj Verma  2
Affiliations

Impact of Fortified Malt-Based Food on Immunity Outcomes in School Children in India: Cluster Randomized Controlled Trial

Anuradha Khadilkar et al. Interact J Med Res. .

Abstract

Background: Nutritional 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.

Objective: We 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.

Methods: This 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 scores (HAZ) of ≥-3 to ≤-1 and good general health. Four schools located in Pune city in India participated in the study. Each school was deemed as a cluster and was randomized to the test group (FMBF and dietary counseling) or control group (dietary counseling alone). A total of 924 participants from the 4 randomized schools were enrolled in the study.

Results: Observed mean age (SD) was 8.0 (SD 0.81; range: 7-10) years. There was no significant difference in mean age (P=.06), gender (P=.55), race (P>.99), HAZ category (P=.051), HAZ (P=.17), and BMI (P=.03). A very large proportion of children had micronutrient inadequacies in terms of vitamin D (97.5%), folate (79.2%), zinc (66%), and vitamin A (34.3%) at baseline. The study design meant that administration of the study intervention at a cluster level was easy. Mean compliance with the test product was 99.99% and retention in the study was 98%.

Conclusions: The 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.

Keywords: Indian children; fortified malt-based food; immunity; multinutrient supplement; school-based; study design.

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Conflict of interest statement

Conflicts of Interest: All authors except AK were employed by the funder (GSK Consumer Healthcare, now Hindustan Unilever Limited) while this clinical study was conducted. AK was the principal investigator for this clinical study and part of the clinical study center.

Figures

Figure 1.
Figure 1.. CONSORT flowchart of study design and participant disposition. CONSORT: Consolidated Standards of Reporting Trials.
See this image and copyright information in PMC

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