Feeding Trial of Bio-fortified Pearl Millet

Iron Deficiency and Anemia Clinical Trial

Official title:

Efficacy of Iron Bio-fortified Pearl Millet in Improving the Iron Status of Adolescents in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152150
• Other study ID #: IRB #: 1107002349
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: May 28, 2014
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2014
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• Participants are individuals aged 12 to 16 years

• Attending boarding schools in Ahmednagar district, Maharashtra, India

Exclusion Criteria:

• Severe anemia (Hemoglobin<8.5g/dL)

• Taking iron supplements or medications that could interfere with iron absorption

• Chronic illnesses

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency and Anemia

Intervention

Other:
• Iron bio-fortified pearl millet
Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri)
• Control pearl millet
Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content), prepared as a traditional flatbread (bhakri)

Locations

Country	Name	City	State
India	S.N.D.T. Women's University	Mumbai

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	S.N.D.T. Women's University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in iron status	Hemoglobin, serum ferritin, serum transferrin receptor, body iron	6 months	No
Secondary	Differences in cognitive function	Five tests of perceptual and cognitive performance: i) the simple reaction time task; ii) the go-nogo task; iii) the attentional network task; iv) the composite face task; and v) the cued recognition memory task.; Approximately 1/2 of participants performed these tasks with concurrent recording of electroencephelography (EEG).	6 months	No
Secondary	Differences in physical performance	i) estimation of maximal oxygen consumption, ii) determination of energy expenditure and work efficiency at modest levels of exertion, and iii) determination of time spent at 3 levels of physical exertion while performing normal daily activities.	6 months	No