Zinc and Iron Bioavailability From Biofortified Pearl Millet

Zinc and Iron Bioavailability From Bio-fortified Pearl Millet

Sponsors

Lead Sponsor: University of Colorado, Denver

Collaborator: Jawaharlal Nehru Medical College
HarvestPlus
International Atomic Energy Agency

Source University of Colorado, Denver
Brief 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.

Overall Status Completed
Start Date 2011-02-01
Completion Date 2012-01-01
Primary Completion Date 2012-01-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Absorption of iron from pearl millet 2 days
Absorption of zinc from pearl millet 1 day
Enrollment 44
Condition
Intervention

Intervention Type: Other

Intervention Name: Pearl millet

Description: Participants in the control arm consume pearl millet which has not been biofortified. The intervention is consumed for two days.

Arm Group Label: Pearl millet

Intervention Type: Other

Intervention Name: Biofortified pearl millet

Description: Participants in the experimental arm consume pearl millet biofortified with iron and zinc. The intervention is consumed for two days.

Arm Group Label: Iron and zinc biofortified pearl millet

Eligibility

Criteria:

Inclusion Criteria: - lives in one of the targeted communities - apparently healthy - 23 m of age [may need modification] - Hemoglobin (Hb) > 8 g/dl - ferritin ≤ 12mg/L Exclusion Criteria: - Hemoglobin (Hb) < 8g/dl - serum ferritin > 12 (even after correction for C-reactive protein (CRP)/ Alpha Glyco Protein (AGP) - thalassemia - birth weight < 2,500 g - birth defect affecting growth and development - chronic infection

Gender:

All

Minimum Age:

18 Months

Maximum Age:

36 Months

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michael Hambidge, MD Principal Investigator University of Colorado, Denver
Location
Facility:
University of Colorado Denver | Aurora, Colorado, 80045, United States
JN Medical College (Human field studies) | Belgaum, Karnataka, India
Location Countries

India

United States

Verification Date

2016-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Iron and zinc biofortified pearl millet

Type: Experimental

Description: Participants in the experimental arm consume pearl millet which has been biofortified with iron and zinc.

Label: Pearl millet

Type: Active Comparator

Description: Participants in the control arm consume non-biofortified pearl millet.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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