The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- iron isotope composition in blood
研究概览
简要总结
Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A new method allowing accurate measurement of long-term oral iron absorption and allowing the estimation of iron requirements is highly needed. Such a novel method to quantify iron absorption and requirements using isotope dilution measurements in children should be validated in the present prospective observational study by following-up a group of 49 children given a stable iron isotope in an earlier trial. We will request seven blood samples within 2 years (sampling every four months) from the participants which will allow us to measure isotopic dilution for estimating total oral iron absorption over these 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have participated in the original absorption study and the two follow-up samplings
- •Signed written informed consent from the guardian to participate in the study
排除标准
- •Long-term medication
- •Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or med-ical examination (health booklet))
- •Blood losses (surgery, accident) or blood transfusion during the past 4 months before study start.
- •Residence too far away (> 2 hours by motorbike) from study location (Zomba)
结局指标
主要结局
iron isotope composition in blood
时间窗: 2 years
the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days
次要结局
未报告次要终点
研究者
Prof. Michael B. Zimmermann
Professor
Swiss Federal Institute of Technology
