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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
223
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.
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.
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
Iron status
Determined by serum ferritin, sTfR, and total body iron
Time frame: Midline serial assessment/sample between months 2-7
Iron status
Determined by serum ferritin, sTfR, and total body iron
Time frame: Endline (nine months)
Physical growth
As determined by length/height, weight, head circumference, and mid-upper arm circumference.
Time frame: Midline serial assessment/sample between months 2-7
Physical growth
As determined by length/height, weight, head circumference, and mid-upper arm circumference.
Time frame: Endline (nine months)
Immune function
Measurement of T cell counts and vaccine response ELISA assays.
Time frame: 1 Midline serial assessment/sample between months 2-7
Immune function
Measurement of T cell counts and vaccine response ELISA assays.
Time frame: Endline (nine months)
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