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Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers

NCT02648893 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-05-26

No results posted yet for this study

Summary

In this study, meals based on multiple food crops (containing either biofortified or commercially-available food crops) will be fed to young children in Madanapalle, Andhra Pradesh, India over a period of nine months to measure growth, cognitive changes, and immune function in comparison to children receiving non-biofortified crops. Mothers of the participating children will also be included in the study.

Conditions

Interventions

OTHER

Multiple biofortified food crops (MBFC-Exp)

Meals from three biofortified food crops will be consumed by children (and potentially their lactating mothers) three times per day, six days per week, for 9 months.

OTHER

Commercially available non-fortified food crops (MBFC-C)

This arm will consume meals based on three commercially available (non-biofortified) food crops three times per day, six days per week, for 9 months.

Sponsors & Collaborators

  • SNDT Women's University

    collaborator OTHER

  • Arogyavaram Medical Centre

    collaborator OTHER

  • Cornell University

    lead OTHER

Principal Investigators

  • Saurabh Mehta, MBBS, ScD · Cornell University

  • Julia L. Finkelstein, ScD · Cornell University

  • Shobha Udipi, PhD · SNDT Women's University

  • Bonam Wesley, MBBS · Arogyavaram Medical Centre

  • Jere D Haas, PhD · Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2021-01-13
Completion
2023-12-31

Countries

  • India

Study Locations

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Entities

Diseases
Companies

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 NCT02648893 on ClinicalTrials.gov