Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India

NCT02233764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2026-03-09

Study results available
· View outcomes & findings →

Summary

In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure iron status, growth and immune function in comparison to children receiving non-biofortified pearl millet.

Conditions

Interventions

OTHER

FeZnPM

Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.

OTHER

CtrlPM

Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.

Sponsors & Collaborators

  • SNDT Women's University

    collaborator OTHER
  • St. John's Research Institute

    collaborator OTHER
  • Center for the Study of Social Change

    collaborator OTHER
  • Cornell University

    lead OTHER

Principal Investigators

  • Saurabh Mehta, MBBS, ScD · Cornell University

  • Jere D. Haas, Ph.D. · Cornell University

  • Julia L. Finkelstein, Sc.D. · Cornell University

  • Richard L. Canfield, Ph.D. · Cornell University

  • Shobha Udipi, Ph.D. · SNDT Women's University

  • Padmini Ghugre · SNDT Women's University

  • R. Potdar · Centre for the Study of Social Change-Mumbai

  • Anura Kurpad · St. John's Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2018-07-16
Completion
2018-07-16

Countries

  • India

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233764 on ClinicalTrials.gov