Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12-18 months in India: study protocol for a randomised controlled trial.

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a randomized controlled trial.

This study aims to investigate the effect of the consumption of foods prepared with iron- and zinc-biofortified pearl millet (FeZn-PM) by children on biomarkers of iron and zinc status, growth, and immune function.

Biological samples will be collected at baseline, midline and endline to assess iron and zinc status, including haemoglobin, serum ferritin, serum transferrin receptor, serum zinc, C-reactive protein and alpha-1 acid glycoprotein.

Why It Was Studied

Biofortified crops represent a sustainable agricultural solution for the widespread micronutrient malnutrition in India and other resource-limited settings.

This study has obtained clearance from the Health Ministry Screening Committee of the Indian Council of Medical Research.

Who Took Part

According to the abstract, 200 children were involved.

The age groups tagged for this paper are infants.

The researchers will conduct a randomised controlled feeding trial in identified slums of Mumbai, India among 200 children aged between 12 and 18 months.

Children will be randomised to receive foods prepared with the biofortified PM (FeZn-PM, ICTP8203-Fe) or non-biofortified PM.

How the Study Was Run

The design is described as randomized.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Biological samples will be archived for future analyses.

The midline measurement will be a random serial sample between baseline and endline.

Immune function will be assessed at each time point by the measurement of T cell counts and vaccine responses in a subset, respectively.

What Was Measured

Topics PubMed links to this paper include Body Height, C-Reactive Protein, Child Development, Cognition, Ferritins, Food, Fortified and Growth Disorders.

Author keywords: biofortification, children, iron, pearl millet and zinc.

What This Means in Plain Language

The paper is a randomized study of Vitamin D, K2, Magnesium and Zinc in 200 children.

The publication is from 2017 (BMJ open), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.