Feeding Trial of Bio-fortified Pearl Millet
Condition: Iron Deficiency and Anemia
MeSH terms: Iron Deficiencies
Study type: Interventional

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.
    

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.
    

Intervention name(s): Iron bio-fortified pearl millet; Control pearl millet
Intervention type(s): Other; Other
Intervention description(s): Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri); Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content), prepared as a traditional flatbread (bhakri)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: iron; anemia; bio-fortification; children; India