Impact of Fortified Malt-Based Food on Immunity Outcomes in School Children in India: Cluster Randomized Controlled Trial
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".