The Effect of Iron Fortification of Complementary Foods on Iron Status and Infant Gut Microbiota in Kenya
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
- 否
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
Prof. Michael B. Zimmermann
Prof
Swiss Federal Institute of Technology
