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Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India

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: NCT02233764
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
SNDT Women's University
St. John's Research Institute
Center for the Study of Social Change
Information provided by (Responsible Party):
Cornell University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Zinc Deficiency Other: FeZnPM Other: CtrlPM Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : July 16, 2018
Actual Study Completion Date : July 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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Arm Intervention/treatment
Experimental: FeZnPM
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
 Other: FeZnPM
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 Name: biofortified pearl millet, bajra, ICTP8203-Fe
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.
 Other: CtrlPM
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 Name: bajra, pearl millet


Outcome Measures
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Primary Outcome Measures :
  1. Iron status [ Time Frame: Midline serial assessment/sample between months 2-7 ]
    Determined by serum ferritin, sTfR, and total body iron

  2. Iron status [ Time Frame: Endline (nine months) ]
    Determined by serum ferritin, sTfR, and total body iron

  3. Physical growth [ Time Frame: Midline serial assessment/sample between months 2-7 ]
    As determined by length/height, weight, head circumference, and mid-upper arm circumference.

  4. Physical growth [ Time Frame: Endline (nine months) ]
    As determined by length/height, weight, head circumference, and mid-upper arm circumference.

  5. Immune function [ Time Frame: 1 Midline serial assessment/sample between months 2-7 ]
    Measurement of T cell counts and vaccine response ELISA assays.

  6. Immune function [ Time Frame: Endline (nine months) ]
    Measurement of T cell counts and vaccine response ELISA assays.


Other Outcome Measures:
  1. Cognitive function [ Time Frame: Midline serial assessment/sample between months 2-7, in a subset ]
    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.

  2. Cognitive function [ Time Frame: Endline (nine months) in a subset ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233764


Locations
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India
Centre for the Study of Social Change-Mumbai
Mumbai, Maharashtra, India, 400 051
St. John's Research Institute
Karnataka, India, 560 034
S.N.D.T. Women's University
Mumbai, India, 400049
Sponsors and Collaborators
Cornell University
SNDT Women's University
St. John's Research Institute
Center for the Study of Social Change
Investigators
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Principal Investigator: Saurabh Mehta, MBBS, ScD Cornell University
Principal Investigator: Jere D. Haas, Ph.D. Cornell University
Principal Investigator: Julia L. Finkelstein, Sc.D. Cornell University
Principal Investigator: Richard L. Canfield, Ph.D. Cornell University
Principal Investigator: Shobha Udipi, Ph.D. SNDT Women's 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT02233764    
Other Study ID Numbers: IRB #: 1403004556
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornell University:
iron
zinc
pearl millet
India
 children
trial
randomized
Additional relevant MeSH terms:
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Iron Deficiencies
Iron Metabolism Disorders
Metabolic Diseases