Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Concentration of NTBI after an oral iron load
研究概览
简要总结
This study aims to investigate a possible effect of iron status on temporary build-up of non-transferrin bound iron (NTBI) in healthy volunteers upon iron supplementation.
详细描述
For Visit 1, blood samples will be collected to assess iron status. For Visit 2, after an overnight fast, iron supplement will be provided to participant before breakfast. Blood samples will be collected right before and 2 h after iron supplement consumption for NTBI analysis.
NTBI concentration before and after iron supplement consumption will be compared. Dependence of NTBI formation on markers of iron status (serum iron, transferrin, transferrin saturation, serum ferritin and hemoglobin) will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy volunteers (21 - 55 years old)
- •C-reactive protein (CRP) < 5
排除标准
- •Blood donation or significant blood loss (e.g. surgery) within the past 4 months
- •Regular intake of iron and other nutrient supplements within the past 4 months
- •Regular intake of medication except oral contraceptives
- •Acute or recent inflammatory or infectious symptoms
- •Chronic gastrointestinal disorders or metabolic diseases
- •Pregnancy or lactation
- •Coeliac disease or gluten-related disorders
- •Iron overload conditions (serum ferritin concentration > 200 ng/mL for females, > 300 ng/mL for males)
- •Non iron deficiency anemia [serum ferritin concentration within normal range (15-200 ng/mL for females, 30-300 ng/mL for males) but low hemoglobin (< 12 g/dL for females, < 14 g/dL for males)]
研究组 & 干预措施
Iron supplement
Ferrous Fumarate tablet 200 mg
干预措施: Ferrous Fumarate (Dietary Supplement)
结局指标
主要结局
Concentration of NTBI after an oral iron load
时间窗: 2 hour post dose
Blood samples collected 2 h after the iron supplement consumption will be measured for NTBI concentration
次要结局
- Dependence of NTBI concentration on markers of iron status (concentrations of serum iron, serum ferritin, transferrin saturation)(2 hour post dose)
研究者
Thomas Walczyk
Associate Professor
National University of Singapore