Study Results
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Basic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2011-09-30
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Iron bio-fortified pearl millet
Pearl millet variety ICTP8203-Fe (82 mg/kg iron content)
Iron bio-fortified pearl millet
Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri)
Control pearl millet
Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content)
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)
Interventions
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Iron bio-fortified pearl millet
Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri)
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)
Eligibility Criteria
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Inclusion Criteria
* Attending boarding schools in Ahmednagar district, Maharashtra, India
Exclusion Criteria
* Taking iron supplements or medications that could interfere with iron absorption
* Chronic illnesses
12 Years
16 Years
ALL
Yes
Sponsors
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SNDT Women's University
OTHER
Cornell University
OTHER
Responsible Party
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Principal Investigators
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Jere D. Haas, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Cornell University
Shobha Udipi, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
SNDT Women's University
Locations
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S.N.D.T. Women's University
Mumbai, , India
Countries
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References
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Wenger MJ, Murray Kolb LE, Scott SP, Boy E, Haas JD. Modeling relationships between iron status, behavior, and brain electrophysiology: evidence from a randomized study involving a biofortified grain in Indian adolescents. BMC Public Health. 2022 Jul 6;22(1):1299. doi: 10.1186/s12889-022-13612-z.
Scott SP, Murray-Kolb LE, Wenger MJ, Udipi SA, Ghugre PS, Boy E, Haas JD. Cognitive Performance in Indian School-Going Adolescents Is Positively Affected by Consumption of Iron-Biofortified Pearl Millet: A 6-Month Randomized Controlled Efficacy Trial. J Nutr. 2018 Sep 1;148(9):1462-1471. doi: 10.1093/jn/nxy113.
Finkelstein JL, Mehta S, Udipi SA, Ghugre PS, Luna SV, Wenger MJ, Murray-Kolb LE, Przybyszewski EM, Haas JD. A Randomized Trial of Iron-Biofortified Pearl Millet in School Children in India. J Nutr. 2015 Jul;145(7):1576-81. doi: 10.3945/jn.114.208009. Epub 2015 May 6.
Other Identifiers
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IRB #: 1107002349
Identifier Type: -
Identifier Source: org_study_id
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