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

Not Applicable

Completed

• Conditions: Zinc Deficiency; Iron Deficiency

• Registration Number: NCT02233764
• Lead Sponsor: Cornell University

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.

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 Timeline

• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-08
• Study Start: 2017-05-08
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immune function	Endline (nine months)	Measurement of T cell counts and vaccine response ELISA assays.
Physical growth	Endline (nine months)	As determined by length/height, weight, head circumference, and mid-upper arm circumference.
Iron status	Endline (nine months)	Determined by serum ferritin, sTfR, and total body iron

Trial Locations

Locations (3)

Centre for the Study of Social Change-Mumbai; 🇮🇳 Mumbai, Maharashtra, India

St. John's Research Institute; 🇮🇳 Karnataka, India

S.N.D.T. Women's University; 🇮🇳 Mumbai, India