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Feeding Trial of Bio-fortified Pearl Millet

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ClinicalTrials.gov Identifier: NCT02152150
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
SNDT Women's University
Information provided by (Responsible Party):
Cornell University

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

Condition or disease Intervention/treatment Phase
Iron Deficiency and Anemia Other: Iron bio-fortified pearl millet Other: Control pearl millet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Iron Bio-fortified Pearl Millet in Improving the Iron Status of Adolescents in India
Study Start Date : September 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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)




Primary Outcome Measures :
  1. Change in iron status [ Time Frame: 6 months ]
    Hemoglobin, serum ferritin, serum transferrin receptor, body iron


Secondary Outcome Measures :
  1. 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).


  2. 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.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152150


Locations
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India
S.N.D.T. Women's University
Mumbai, India
Sponsors and Collaborators
Cornell University
SNDT Women's University
Investigators
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Principal Investigator: Jere D. Haas, Ph.D. Cornell University
Principal Investigator: Shobha Udipi, Ph.D. SNDT Women's University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT02152150     History of Changes
Other Study ID Numbers: IRB #: 1107002349
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by Cornell University:
iron
anemia
bio-fortification
children
India
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs