Optimizing Oral Iron Supplementation Regimens During Pregnancy Using Serum Hepcidin Profiles and Iron Stable Isotopes: Defining a Dosing Regimen With Maximal Absorption and Minimal Gastrointestinal Side Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Total iron absorption in %
研究概览
简要总结
Iron deficiency anemia (IDA) is common during pregnancy and has adverse effects on the mother, fetus and newborn. Oral iron supplements are usually recommended to prevent ID/IDA during pregnancy.
The aim of this study is to define an iron supplementation schedule with maximal absorption using serum hepcidin profiles and stable iron isotopes in pregnant women. In this randomized, open-label trial, fractional and total iron absorption will be compared from daily dosing with 60 mg iron versus alternate day and every third day dosing with 120 mg iron in pregnant Thai women with low iron stores (n=28) during their second trimester of pregnancy.
This study could have wide impact, providing the evidence base for revised, improved recommendations for iron supplementation during pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •gestational week 14-16 at study start
- •singleton pregnancy
- •Serum ferritin SF <60 µg/L
- •non-anemic or mildly anemic, defined as hemoglobin (Hb) >10 g/dL
- •female aged 18-45 years
- •healthy Thai woman
排除标准
- •acute or chronic disease
- •taking medications that could influence iron absorption
结局指标
主要结局
Total iron absorption in %
时间窗: Day 53
Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose
Fractional iron absorption in %
时间窗: Day 53
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin
时间窗: Day 53
in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle
次要结局
- Hemoglobin (Hb)(Day 53)
- Soluble transferrin receptor (sTfR)(Day 53)
- Serum Ferritin (SF)(Day 53)
- Alpha-1-acid glycoprotein (AGP)(Day 53)
- Serum Hepcidin(Day 53)
- C-reactive protein (CRP)(Day 53)
- Total Iron Binding Capacity (TIBC)(Day 53)
- Serum Iron (SFe)(Day 53)
研究者
Prof. Michael B. Zimmermann
Prof.Dr.
Swiss Federal Institute of Technology