Maximizing the Benefits of Iron in Ready-to-use Therapeutic Foods for Malnourished Children in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Fractional Iron Absorption
研究概览
简要总结
Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia. The current RUTF formulation may have an excessively high iron content. In severely acutely malnourished (SAM) children, iron cannot be properly absorbed, leading to life-threatening diarrhea. The overall aim of this project is to develop an improved RUTF treatment that addresses acute malnutrition and anemia in children, ensuring both safety and efficacy. Specifically, to assess the impact of malnutrition on fractional iron absorption (FIA) from RUTFs in children, by comparing healthy children to those with acute malnutrition and by tracking changes in FIA in malnourished children over the course of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •malnourished children:
- •severe acute malnutrition (SAM): WHZ < -3.0
- •moderate acute malnutrition (MAM): WHZ < -2.0 a
- •treated as outpatients (no acute medical conditions and a positive appetite test)
- •healthy children:
- •- healthy: HAZ, WAZ and WHZ = 0
排除标准
- •(both groups):
- •Hemoglobin ≤7 g/dL
- •Presence of acute medical conditions requiring inpatient management
结局指标
主要结局
Fractional Iron Absorption
时间窗: Day 0
Fractional Iron Absorption
时间窗: Day 20
Fractional Iron Absorption
时间窗: Day 40
Fractional Iron Absorption
时间窗: Day 60
次要结局
- body height(Day 20)
- body height(Day 40)
- Hemoglobin(Day 0)
- Hemoglobin(Day 20)
- Hemoglobin(Day 40)
- Hemoglobin(Day 60)
- Serum Ferritin(Day 20)
- Serum Ferritin(Day 40)
- soluble transferrin receptor(Day 0)
- soluble transferrin receptor(Day 20)
- soluble transferrin receptor(Day 40)
- C-reactive protein(Day 0)
- C-reactive protein(Day 20)
- C-reactive protein(Day 40)
- α₁-acid glycoprotein(Day 0)
- α₁-acid glycoprotein(Day 20)
- α₁-acid glycoprotein(Day 40)
- body weight(Day 0)
- body weight(Day 20)
- body weight(Day 40)
- body height(Day 0)
- Hemoglobin(Day 80)
- Serum ferritin(Day 0)
- Serum Ferritin(Day 60)
- soluble transferrin receptor(Day 60)
- C-reactive protein(Day 60)
- α₁-acid glycoprotein(Day 60)
- body weight(Day 60)
- body height(Day 60)
研究者
Nicole Stoffel
Assistantprofessor
ETH Zurich