Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 3
- 主要终点
- Hemoglobin (g/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
- •Hemoglobin ≥9 g/dL
排除标准
- •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
研究组 & 干预措施
FeZnPM
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
干预措施: FeZnPM (Other)
CtrlPM
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.
干预措施: CtrlPM (Other)
结局指标
主要结局
Hemoglobin (g/dL)
时间窗: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
As determined by hemoglobin concentration
Hemoglobin (g/dL)
时间窗: 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
Iron Status
时间窗: 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
Iron Status
时间窗: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin
Iron Status BRINDA Adjusted
时间窗: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin BRINDA adjusted
Iron Status BRINDA Adjusted
时间窗: 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
Physical Growth
时间窗: 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.
Physical Growth
时间窗: 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.
Immune Function
时间窗: 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).
Immune Function
时间窗: 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
次要结局
未报告次要终点