Clinical trial NCT02152150: Feeding Trial of Bio-fortified Pearl Millet
Official title: Efficacy of Iron Bio-fortified Pearl Millet in Improving the Iron Status of Adolescents in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency and Anemia
Keywords: iron
anemia
bio-fortification
children
India
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: SNDT Women's University
First posted: 2014-06-02
Enrollment: 246
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in iron status
timeFrame: 6 months
Secondary outcomes:
measure: Differences in cognitive function
timeFrame: 6 months
measure: Differences in physical performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: S.N.D.T. Women's University
Study officials:
affiliation: Cornell University
name: Jere D. Haas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SNDT Women's University
name: Shobha Udipi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wenger MJ, Murray Kolb LE, Scott SP, Boy E, Haas JD. Modeling relationships between iron status, behavior, and brain electrophysiology: evidence from a randomized study involving a biofortified grain in Indian adolescents. BMC Public Health. 2022 Jul 6;22(1):1299. doi: 10.1186/s12889-022-13612-z.
citation: Scott SP, Murray-Kolb LE, Wenger MJ, Udipi SA, Ghugre PS, Boy E, Haas JD. Cognitive Performance in Indian School-Going Adolescents Is Positively Affected by Consumption of Iron-Biofortified Pearl Millet: A 6-Month Randomized Controlled Efficacy Trial. J Nutr. 2018 Sep 1;148(9):1462-1471. doi: 10.1093/jn/nxy113.
citation: Finkelstein JL, Mehta S, Udipi SA, Ghugre PS, Luna SV, Wenger MJ, Murray-Kolb LE, Przybyszewski EM, Haas JD. A Randomized Trial of Iron-Biofortified Pearl Millet in School Children in India. J Nutr. 2015 Jul;145(7):1576-81. doi: 10.3945/jn.114.208009. Epub 2015 May 6.