Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Changes in GI microbiome
研究概览
简要总结
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.
详细描述
Specific aims include exploration of possible mechanisms of adverse events that have been observed in iron supplementation trials in infants in malaria endemic regions by:
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Characterizing the impact of enteral iron administration on the evolution of the intestinal microbiome in infants from 6 to 9 months of age.
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Characterizing iron administration-associated inflammatory responses and correlate these with changes in the intestinal microbiome in infants from 6 to 9 months of age. Specifically, changes in the microbiome will be correlated with biomarkers reflecting:
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Intestinal inflammation;
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Systemic inflammation, bacterial translocation, and oxidant stress;
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Iron status and homeostasis
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Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infant
- •Birthweight > 2500 g
- •Healthy with no apparent congenital anomalies
- •Up-to-date with vaccinations
- •Hb >10 g/dL
- •Breastfeeding with intent to continue for duration of study
- •Negative blood slide for malaria
- •Written informed consent
排除标准
- •Acute malnutrition
- •Current or anticipated used of infant formula or other fortified products
- •Current or planned use of iron (or zinc) supplements
- •Previous hospitalization for malaria within the last four weeks
- •Persistent diarrhea
研究组 & 干预措施
Micronutrient Powder (MNP) + Zn/Fe
Micronutrient Powder with 5 mg Zn and 12 mg Fe
干预措施: MNP + Zn/Fe (Dietary Supplement)
MNP + Zn
Micronutrient Powder with 5 mg Zn
干预措施: MNP + Zn (Dietary Supplement)
Control
Placebo sachets without micronutrients
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in GI microbiome
时间窗: 6 and 9 months of age
Identify and quantify the phylogenic distribution of bacterial genera in the infants from 6 to 9 months in prevalence or abundance with iron supplementation at baseline, mid-point and 9 months.
次要结局
- Absorption of Zn(9 months of age)
- Size of exchangeable Zn pool(9 months of age)
- Change in Biomarkers of bacterial translocation(6 and 9 mo of age)
- Change in Biomarkers of intestinal and system inflammation(6 and 9 months of age)
- Change in Biomarkers of oxidative stress(6 and 9 mo of age)