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

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 iron status, growth and immune function in comparison to children receiving non-biofortified pearl millet.

Iron deficiency remains a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 223 children aged 12-18 months from Mumbai, Maharashtra, India were 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 was to examine the effects of iron and zinc-biofortified millet on markers of iron status, growth, and immune function in this age group. The key outcome measures were biomarkers of iron status, physical growth, and immune function defined as response to measles vaccine. Concentrations of serum ferritin and hemoglobin as well as markers of immune function were assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endpoint). Additionally, we measured concentrations of C-reactive protein (CRP), as iron biomarkers can be influenced by inflammation. Growth was assessed monthly for 9 months and expressed as anthropometric Z-scores.

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