Clinical Study to Measure the Impact of Fortified Malt-Based Food on Immunity Outcomes in School Children in India: Epidemiology, Baseline Characteristics, and Design Science (Use of multi-nutrient supplement in school children) (Preprint)

Abstract

Nutritional inadequacy and consequent diminished immunity among school age children is a public health problem in India.

We tested the hypothesis that daily administration of a fortified malt-based food (FMBF), a multi-nutrient supplement, would improve immunity outcomes against common infectious diseases, nutritional status (biochemical, anthropometric, and dietary) and gut health in Indian school-age children.

This report presents the study design attributes and the baseline characteristics of the study population. This was an open-label, two-arm, parallel-group, matched-pair cluster randomized controlled trial (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 test group (FMBF + dietary counselling) or control group (dietary counselling alone).

A total of 924 participants from the 4 randomized schools were enrolled in the study. A very large proportion of children had micronutrient inadequacies in terms of vitamin D (97.51%), folate (79.18%), zinc (66.05%), and vitamin A (34.27%) at baseline. Cluster RCT design was effectively used in this nutritional intervention trial with high compliance (97%) and overall high retention (98%).

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.

Clinicaltrial.gov: NCT02542865