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临床试验/NCT01111864
NCT01111864已完成不适用

The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya

Swiss Federal Institute of Technology1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
gut microbiota composition

研究概览

简要总结

Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food.

The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants.

Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
24 Weeks 至 28 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Mother at least ≥15 years of age, infants 5.5- 6.5 months
  • Willingness to provide informed consent
  • Apparent good health
  • Long-term residence in study site and anticipating residing in the area for at least 3 years
  • Speak a Mjikenda language or Kiswahili in the home
  • Willingness to provide blood samples during clinic visits

排除标准

  • Hemoglobin <70 g/L for infants; these infants will be referred for treatment at the local health clinic/hospital.
  • Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition or any other finding that in the opinion of the PI or co-researchers that would increase risk of participating in the study.
  • Other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol

结局指标

主要结局

gut microbiota composition

时间窗: Fecal sample after 2 months

Changes in gut microbiota composition

次要结局

  • iron status(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Michael B. Zimmermann

Prof

Swiss Federal Institute of Technology

研究点 (1)

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