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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India

Conditions
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Iron Deficiency, Zinc Deficiency

Intervention / Treatment
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* Other: FeZnPM
* Other: CtrlPM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FeZnPM<br>The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe). | Other: FeZnPM<br>* 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.<br>* Other names: biofortified pearl millet, bajra, ICTP8203-Fe;|
| Active Comparator: CtrlPM<br>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<br>* 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.<br>* Other names: bajra, pearl millet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron status | Determined by serum ferritin, sTfR, and total body iron | Midline serial assessment/sample between months 2-7 | 
| Iron status | Determined by serum ferritin, sTfR, and total body iron | Endline (nine months) | 
| Physical growth | As determined by length/height, weight, head circumference, and mid-upper arm circumference. | Midline serial assessment/sample between months 2-7 | 
| Physical growth | As determined by length/height, weight, head circumference, and mid-upper arm circumference. | Endline (nine months) | 
| Immune function | Measurement of T cell counts and vaccine response ELISA assays. | 1 Midline serial assessment/sample between months 2-7 | 
| Immune function | Measurement of T cell counts and vaccine response ELISA assays. | Endline (nine months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, zinc, pearl millet, India, children, trial, randomized