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

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

SUBMITTER: Khadilkar A 

PROVIDER: S-EPMC12242860 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature