Iron Deficiency and Anemia Clinical Trial
Official title:
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention