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

January 29, 2019 updated by: Cornell University

Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India

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 growth and immune function in comparison to children receiving non-biofortified pearl millet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Iron and zinc deficiency remain a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 700 children aged 12-18 months from Mumbai, Maharashtra, India will be fed either iron and zinc biofortified pearl millet or control pearl millet three times per day, six days per week, for nine months. The goal of this study is to examine the effects of iron and zinc biofortified millet on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin, ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To assess cognitive function in a subset, multiple specific aspects of memory, attention, and processing speed will be assessed. Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed.

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Karnataka, India, 560 034
        • St. John's Research Institute
      • Mumbai, India, 400049
        • S.N.D.T. Women's University
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 051
        • Centre for the Study of Social Change-Mumbai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
  • Hemoglobin ≥9 g/dL

Exclusion Criteria:

  • Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
  • Hemoglobin < 9 g/dL and/or hemoglobinopathy
  • Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3)
  • Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS, malaria, Dengue fever, Tuberculosis requiring >1 day hospitalization
  • Children who do not have a caretaker to bring him/her to feeding center
  • Possibility of migrating out of the slum dwelling for longer than 4 weeks
  • Prior or current consumption of iron or zinc supplements in the past 1 year
  • Any known dietary allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FeZnPM
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
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 Names:
  • biofortified pearl millet, bajra, ICTP8203-Fe
Active Comparator: CtrlPM
The CtrlPM arm will consume conventional pearl millet 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.
Other Names:
  • bajra, pearl millet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron status
Time Frame: Midline serial assessment/sample between months 2-7
Determined by serum ferritin, sTfR, and total body iron
Midline serial assessment/sample between months 2-7
Iron status
Time Frame: Endline (nine months)
Determined by serum ferritin, sTfR, and total body iron
Endline (nine months)
Physical growth
Time Frame: Midline serial assessment/sample between months 2-7
As determined by length/height, weight, head circumference, and mid-upper arm circumference.
Midline serial assessment/sample between months 2-7
Physical growth
Time Frame: Endline (nine months)
As determined by length/height, weight, head circumference, and mid-upper arm circumference.
Endline (nine months)
Immune function
Time Frame: 1 Midline serial assessment/sample between months 2-7
Measurement of T cell counts and vaccine response ELISA assays.
1 Midline serial assessment/sample between months 2-7
Immune function
Time Frame: Endline (nine months)
Measurement of T cell counts and vaccine response ELISA assays.
Endline (nine months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Midline serial assessment/sample between months 2-7, in a subset
Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.
Midline serial assessment/sample between months 2-7, in a subset
Cognitive function
Time Frame: Endline (nine months) in a subset
Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.
Endline (nine months) in a subset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornell University

Collaborators

St. John's Research Institute
SNDT Women's University
Center for the Study of Social Change

Investigators

  • Principal Investigator: Saurabh Mehta, MBBS, ScD, Cornell University
  • Principal Investigator: Jere D. Haas, Ph.D., Cornell University
  • Principal Investigator: Shobha Udipi, Ph.D., SNDT Women's University
  • Principal Investigator: Julia L. Finkelstein, Sc.D., Cornell University
  • Principal Investigator: Richard L. Canfield, Ph.D., Cornell University
  • Principal Investigator: Padmini Ghugre, SNDT Women's University
  • Principal Investigator: R. Potdar, Centre for the Study of Social Change-Mumbai
  • Principal Investigator: Anura Kurpad, St. John's Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2017

Primary Completion (Actual)

July 16, 2018

Study Completion (Actual)

July 16, 2018

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #: 1403004556

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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