Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feeding Trial of Bio-fortified Pearl Millet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152150
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
SNDT Women's University
Information provided by (Responsible Party):
Cornell University

Tracking Information
First Submitted Date  ICMJE May 13, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date June 2, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Change in iron status [ Time Frame: 6 months ]
Hemoglobin, serum ferritin, serum transferrin receptor, body iron
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Differences in cognitive function [ Time Frame: 6 months ]
    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).
  • Differences in physical performance [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feeding Trial of Bio-fortified Pearl Millet
Official Title  ICMJE Efficacy of Iron Bio-fortified Pearl Millet in Improving the Iron Status of Adolescents in India
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Iron Deficiency and Anemia
Intervention  ICMJE
  • Other: Iron bio-fortified pearl millet
    Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri)
  • Other: 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)
Study Arms  ICMJE
  • Experimental: Iron bio-fortified pearl millet
    Pearl millet variety ICTP8203-Fe (82 mg/kg iron content)
    Intervention: Other: Iron bio-fortified pearl millet
  • Active Comparator: Control pearl millet
    Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content)
    Intervention: Other: Control pearl millet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
246
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152150
Other Study ID Numbers  ICMJE IRB #: 1107002349
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cornell University
Study Sponsor  ICMJE Cornell University
Collaborators  ICMJE SNDT Women's University
Investigators  ICMJE
Principal Investigator: Jere D. Haas, Ph.D. Cornell University
Principal Investigator: Shobha Udipi, Ph.D. SNDT Women's University
PRS Account Cornell University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP