Clinical trial NCT01783067: Zinc and Iron Bioavailability From Biofortified Pearl Millet
Official title: Zinc and Iron Bioavailability From Bio-fortified Pearl Millet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Keywords: Biofortification
Pearl millet
Iron absorption
Zinc absorption
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Jawaharlal Nehru Medical College
name: HarvestPlus
name: International Atomic Energy Agency
First posted: 2013-02-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Absorption of iron from pearl millet
timeFrame: 2 days
measure: Absorption of zinc from pearl millet
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Belgaum
country: India
facility: JN Medical College (Human field studies)
state: Karnataka
Study officials:
affiliation: University of Colorado, Denver
name: Michael Hambidge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kodkany BS, Bellad RM, Mahantshetti NS, Westcott JE, Krebs NF, Kemp JF, Hambidge KM. Biofortification of pearl millet with iron and zinc in a randomized controlled trial increases absorption of these minerals above physiologic requirements in young children. J Nutr. 2013 Sep;143(9):1489-93. doi: 10.3945/jn.113.176677. Epub 2013 Jul 10.
citation: Miller LV, Hambidge KM, Krebs NF. Zinc Absorption Is Not Related to Dietary Phytate Intake in Infants and Young Children Based on Modeling Combined Data from Multiple Studies. J Nutr. 2015 Aug;145(8):1763-9. doi: 10.3945/jn.115.213074. Epub 2015 Jun 24.