- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02233764
Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India
January 29, 2019 updated by: Cornell University
Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India
In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function in comparison to children receiving non-biofortified pearl millet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Iron and zinc deficiency remain a major worldwide public health problem, especially in developing countries such as India.
In this randomized study, 700 children aged 12-18 months from Mumbai, Maharashtra, India will be fed either iron and zinc biofortified pearl millet or control pearl millet three times per day, six days per week, for nine months.
The goal of this study is to examine the effects of iron and zinc biofortified millet on immune function, growth, and cognitive function in this age group.
The key outcome measures are biomarkers of iron and zinc status, growth, and immune function.
Serum concentrations of hemoglobin, ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline).
Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation.
To assess cognitive function in a subset, multiple specific aspects of memory, attention, and processing speed will be assessed.
Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed.
Study Type
Interventional
Enrollment (Actual)
223
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karnataka, India, 560 034
- St. John's Research Institute
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Mumbai, India, 400049
- S.N.D.T. Women's University
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Maharashtra
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Mumbai, Maharashtra, India, 400 051
- Centre for the Study of Social Change-Mumbai
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
- Hemoglobin ≥9 g/dL
Exclusion Criteria:
- Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
- Hemoglobin < 9 g/dL and/or hemoglobinopathy
- Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3)
- Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS, malaria, Dengue fever, Tuberculosis requiring >1 day hospitalization
- Children who do not have a caretaker to bring him/her to feeding center
- Possibility of migrating out of the slum dwelling for longer than 4 weeks
- Prior or current consumption of iron or zinc supplements in the past 1 year
- Any known dietary allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FeZnPM
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
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Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months.
Children are anticipated to consume 25-30 grams of the pearl millet at each feeding.
The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
Other Names:
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Active Comparator: CtrlPM
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months.
Children are anticipated to consume 25-30 grams of the pearl millet at each feeding.
The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
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Conventional pearl millet will be consumed three times per day, six days per week, for 9 months.
Children are anticipated to consume 25-30 grams of the pearl millet at each feeding.
The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron status
Time Frame: Midline serial assessment/sample between months 2-7
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Determined by serum ferritin, sTfR, and total body iron
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Midline serial assessment/sample between months 2-7
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Iron status
Time Frame: Endline (nine months)
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Determined by serum ferritin, sTfR, and total body iron
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Endline (nine months)
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Physical growth
Time Frame: Midline serial assessment/sample between months 2-7
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As determined by length/height, weight, head circumference, and mid-upper arm circumference.
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Midline serial assessment/sample between months 2-7
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Physical growth
Time Frame: Endline (nine months)
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As determined by length/height, weight, head circumference, and mid-upper arm circumference.
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Endline (nine months)
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Immune function
Time Frame: 1 Midline serial assessment/sample between months 2-7
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Measurement of T cell counts and vaccine response ELISA assays.
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1 Midline serial assessment/sample between months 2-7
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Immune function
Time Frame: Endline (nine months)
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Measurement of T cell counts and vaccine response ELISA assays.
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Endline (nine months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: Midline serial assessment/sample between months 2-7, in a subset
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Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.
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Midline serial assessment/sample between months 2-7, in a subset
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Cognitive function
Time Frame: Endline (nine months) in a subset
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Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.
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Endline (nine months) in a subset
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Saurabh Mehta, MBBS, ScD, Cornell University
- Principal Investigator: Jere D. Haas, Ph.D., Cornell University
- Principal Investigator: Shobha Udipi, Ph.D., SNDT Women's University
- Principal Investigator: Julia L. Finkelstein, Sc.D., Cornell University
- Principal Investigator: Richard L. Canfield, Ph.D., Cornell University
- Principal Investigator: Padmini Ghugre, SNDT Women's University
- Principal Investigator: R. Potdar, Centre for the Study of Social Change-Mumbai
- Principal Investigator: Anura Kurpad, St. John's Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12 to 18 months living in urban slums. Clin Nutr. 2022 Apr;41(4):937-947. doi: 10.1016/j.clnu.2022.02.014. Epub 2022 Feb 24.
- Huey SL, Finkelstein JL, Venkatramanan S, Udipi SA, Ghugre P, Thakker V, Thorat A, Potdar RD, Chopra HV, Kurpad AV, Haas JD, Mehta S. Prevalence and Correlates of Undernutrition in Young Children Living in Urban Slums of Mumbai, India: A Cross Sectional Study. Front Public Health. 2019 Jul 12;7:191. doi: 10.3389/fpubh.2019.00191. eCollection 2019.
- Mehta S, Finkelstein JL, Venkatramanan S, Huey SL, Udipi SA, Ghugre P, Ruth C, Canfield RL, Kurpad AV, Potdar RD, Haas JD. Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12-18 months in India: study protocol for a randomised controlled trial. BMJ Open. 2017 Nov 14;7(11):e017631. doi: 10.1136/bmjopen-2017-017631. Erratum In: BMJ Open. 2018 Jan 9;8(1):e017631corr1. BMJ Open. 2018 Oct 2;8(10):e017631corr2.
- Huey SL, Venkatramanan S, Udipi SA, Finkelstein JL, Ghugre P, Haas JD, Thakker V, Thorat A, Salvi A, Kurpad AV, Mehta S. Acceptability of Iron- and Zinc-Biofortified Pearl Millet (Dhanashakti)-Based [corrected] Complementary Foods among Children in an Urban Slum of Mumbai, India. Front Nutr. 2017 Aug 25;4:39. doi: 10.3389/fnut.2017.00039. eCollection 2017. Erratum In: Front Nutr. 2018 Oct 18;5:92.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2017
Primary Completion (Actual)
July 16, 2018
Study Completion (Actual)
July 16, 2018
Study Registration Dates
First Submitted
September 4, 2014
First Submitted That Met QC Criteria
September 4, 2014
First Posted (Estimate)
September 8, 2014
Study Record Updates
Last Update Posted (Actual)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 29, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #: 1403004556
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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