Dietary Iron Absorption From Lipid-Based Nutrient Supplements - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dietary iron absorption
研究概览
简要总结
The overall objective of this study is to determine dietary iron absorption from lipid-based nutrient supplements (LNS) in apparently healthy and undernourished children. This case-control study will recruit apparently healthy children and children with uncomplicated undernutrition (age 1-3 years, n=15/group) from Msambweni and the surrounding rural communities in Kwale County, Kenya. At the baseline visit (day 0), participants will be provided with an LNS labeled with a stable iron isotope (57-Fe). Participants will return to the hospital 14 days later (day 14) for a blood draw. Blood collected on day 14 will be used to measure iron isotope incorporation into red blood cells. Blood collected at screening will be used to measure indicators of anemia, iron status, hepcidin, and inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children age 1-3 years on day of screening visit
- •Hemoglobin 8-11 g/dL on day of screening visit
- •Undernourished [length/height-for-age z-score (HAZ), weight-for-age z-score (WAZ), and/or weight-for-height/length z-score (WHZ) < -2] OR apparently healthy (HAZ, WAZ, and/or WHZ ≥ -1)
排除标准
- •Severe acute malnutrition (WHZ < -3) with no appetite
- •Serious medical condition or other chronic disease besides undernutrition (e.g., HIV+, severe pneumonia, malaria)
- •Peanut allergy or other allergy that prevents consumption of the LNS
- •Plans to move away from the study location during the study period
结局指标
主要结局
Dietary iron absorption
时间窗: Isotope incorporation into RBCs on day 14
次要结局
- Hemoglobin(Measured at screening)
- Serum ferritin(Measured at screening)
- Hepcidin(Measured at screening)
- Soluble transferrin receptor(Measured at screening)
- Transferrin saturation(Measured at screening)
- C-reactive protein(Measured at screening)
- Alpha-1-acid glycoprotein(Measured at screening)
研究者
Stephen Hennigar
Associate Professor
Pennington Biomedical Research Center