Zinc and Iron Bioavailability From Biofortified Pearl Millet
Condition: Nutritional Deficiency
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Populations who consume non-fortified plant-based diets are at increased risk of iron and
      zinc deficiencies. The purpose of this randomized controlled study is to determine the
      absorption of iron and zinc from pearl millet biofortified with these two micronutrients.
      Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl
      millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron
      absorbed are measured with established stable isotope extrinsic labeling techniques and
      analyses of duplicate diets.
    

Detailed description: 
      Nutritional deficiency of iron in 30-70% of young children in different communities in India
      is well documented and has proved challenging to eradicate both in India and globally. Less
      is known about zinc deficiency, but zinc and iron are generally present in the same foods and
      there is also growing evidence for the public health importance of zinc deficiency in young
      children on a global basis. In populations that depend primarily on plant-based foods,
      biofortification of major food staples by traditional selective plant breeding procedures
      offers an attractive strategy for preventing iron and zinc deficiency in all age groups.
      Pearl millet, a major food staple in several areas of India, has both naturally relatively
      high concentrations of iron and zinc with demonstrated potential to increase these levels
      further with plant breeding. Before embarking on complex, costly efficacy, effectiveness
      studies of the potential health benefits of this biofortified grain, the objective of this
      project is to determine the extent to which iron and zinc absorption is increased in very
      young children who consume pearl millet as the primary grain and major food staple. This is a
      short term, cross-sectional double-blinded study in which the test or control pearl millet is
      fed for a total of 9 days. Primary outcome measures are the increases in iron and zinc
      absorption over a two-day period. Test meals will be labeled with a zinc stable isotope on
      Day 8 and an iron stable isotope on Days 8 and 9 during which days participants and their
      mothers will stay in their community health center. Food intake will be weighed and duplicate
      diets obtained. Percentage iron absorption will be determined from erythrocyte enrichment on
      Day 23. Fractional zinc absorption will be measured from urine enrichment with orally and
      intravenously administered zinc isotopes from timed samples collected on Days 12-15. Daily
      absorption of these minerals will be determined. Increases in intake and absorption of these
      minerals (mg/d) will be evaluated with respect to estimated dietary and physiologic
      requirements.
    

Intervention name(s): Pearl millet; Biofortified pearl millet
Intervention type(s): Other; Other
Intervention description(s): Participants in the control arm consume pearl millet which has not been biofortified. The intervention is consumed for two days.; Participants in the experimental arm consume pearl millet biofortified with iron and zinc. The intervention is consumed for two days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Biofortification; Pearl millet; Iron absorption; Zinc absorption