NCT Number: NCT02233764
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.
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Notify Me12 month–18 month
All sexes
Interventional
Not applicable
St. John's Research Institute, Bengaluru, Karnataka, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: biofortified pearl millet, bajra, ICTP8203-Fe
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 names: bajra, pearl millet
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
As determined by hemoglobin concentration
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
As determined by hemoglobin concentration
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin BRINDA adjusted
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Serum ferritin BRINDA adjusted
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Weight-for-age Z-score (child's body weight as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Weight-for-age Z-score (child's body weight as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune responses primarily defined as protective anti-measles IgG titers (>16.5 AU/mL).
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune responses primarily defined as response to measles vaccine
Cornell University
Other
Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India
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