Feeding Trial of Bio-fortified Pearl Millet

May 28, 2014 updated by: Cornell University

Efficacy of Iron Bio-fortified Pearl Millet in Improving the Iron Status of Adolescents in India

The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet in improving iron status in adolescents in India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An estimated 1.6 billion people worldwide are anemic, and iron deficiency (ID) is the leading cause of anemia. Its prevalence is highest in resource-limited settings, and among children and women of reproductive age. Even mild ID can adversely impact cognitive performance, behavior, and physical growth of children, and physical work and cognitive performance in adults.

Interventions to target micronutrient malnutrition such as dietary diversification, micronutrient supplementation, and food fortification have reduced ID, but have not been universally successful. Biofortification, the process of increasing the concentration and bioavailability of essential nutrients in staple crops by traditional plant breeding, is a sustainable and cost-effective approach to combat micronutrient deficiencies. Other forms of bio-fortification (agronomic management and genetic modification) are also feasible. Rice, maize, wheat, pearl millet, sweet potato, beans, and cassava have been the main target crops of bio-fortification.

Pearl millet (PM) is a primary staple food in India, particularly in the states of Rajasthan, Gujarat and Maharashtra. The high pearl millet consumption and availability of a recently released pearl millet variety (ICTP 8203-Fe) with significantly greater iron content provided an opportunity to evaluate its efficacy on improving iron status in human populations. We hypothesized that daily consumption of iron bio-fortified pearl millet (Fe-PM) would improve iron status in six months. We conducted a randomized efficacy trial of iron bio-fortified pearl millet in improving iron status in adolescents in Maharashtra, India.

The aims of this study are:

  • To determine if the iron status of adolescent boys and girls in rural Maharashtra is improved by consuming high-iron bio-fortified PM
  • To determine if adolescents in rural Maharashtra consuming high-iron bio-fortified PM exhibit higher physical performance and energetic work efficiency compared to adolescent boys and girls consuming low-iron pearl millet.
  • To determine if adolescents in rural Maharashtra consuming high-iron bio-fortified PM exhibit higher cognitive and perceptual functioning, as well as differences in patterns of cortical activation' when compared to children consuming low-iron pearl millet.

The principal hypotheses to be tested are that in an intervention study using iron bio-fortified PM with the highest possible levels of iron content in comparison to a low-iron control:

  • Iron bio-fortified PM consumed as a dietary iron intervention will improve the iron status of iron deficient adolescents
  • Iron bio-fortified PM consumed as a dietary iron intervention will improve the physical performance of iron deficient adolescents
  • Iron bio-fortified PM as an iron intervention will improve the cognitive and perceptual functioning of iron deficient adolescents

The long-term goal of this study is to show that iron bio-fortification of PM is an efficacious and potentially effective strategy for addressing iron deficiency in developing countries.

Study Type

Interventional

Enrollment (Actual)

246

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
      • Mumbai, India
        • S.N.D.T. Women's University

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

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants are individuals aged 12 to 16 years
  • Attending boarding schools in Ahmednagar district, Maharashtra, India

Exclusion Criteria:

  • Severe anemia (Hemoglobin<8.5g/dL)
  • Taking iron supplements or medications that could interfere with iron absorption
  • Chronic illnesses

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron bio-fortified pearl millet
Pearl millet variety ICTP8203-Fe (82 mg/kg iron content)
Other: Iron bio-fortified pearl millet
Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri)
Active Comparator: Control pearl millet
Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content)
Other: Control pearl millet
Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content), prepared as a traditional flatbread (bhakri)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in iron status
Time Frame: 6 months
Hemoglobin, serum ferritin, serum transferrin receptor, body iron
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in cognitive function
Time Frame: 6 months

Five tests of perceptual and cognitive performance: i) the simple reaction time task; ii) the go-nogo task; iii) the attentional network task; iv) the composite face task; and v) the cued recognition memory task.

Approximately 1/2 of participants performed these tasks with concurrent recording of electroencephelography (EEG).
6 months
Differences in physical performance
Time Frame: 6 months
i) estimation of maximal oxygen consumption, ii) determination of energy expenditure and work efficiency at modest levels of exertion, and iii) determination of time spent at 3 levels of physical exertion while performing normal daily activities.
6 months

Collaborators and Investigators

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

Sponsor

Cornell University

Collaborators

SNDT Women's University

Investigators

  • Principal Investigator: Jere D. Haas, Ph.D., Cornell University
  • Principal Investigator: Shobha Udipi, Ph.D., SNDT Women's University

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

September 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #: 1107002349

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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