Randomized Open Comparative Trial of Oral Sucrosomial Iron (SiderAl Forte®) and Oral Iron Sulphate (Duroferon®) to Blood Donors.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Side effects
研究概览
简要总结
2 different oral iron supplementations after blood donation are compared.
详细描述
Iron depletion is common in regular blood donors. During a blood donation the donor loses 200-250 mg iron. The routine at our donor sites is to give donors 20 tablets of iron sulphate (Duroferon®) 100 mg after blood donation.
In this study we will compare two different iron supplementations given after blood donation. 60 donors are given oral sucrosomial Iron (SiderAl Forte®) and 60 donors are given oral iron sulphate (Duroferon®) after 4 successive blood donation.
The primary purpose of this study is to compare the side effects of sucrosomial Iron and iron sulphate and to investigate if the iron balance can be maintained with sucrosomial iron.
After each blood donation the donors are asked to answer a questionary with questions about side effects and symptoms of Restless legs syndrome/Willis-Ekbom (symptoms associated with iron deficiency).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Blood donors at Uppsala University hospital wo have been donating blood regularly the last two years are eligible to participate in the study.
排除标准
- •Donors who cannot be accepted for blood donation anymore because they do not fulfill the Swedish criteria for blood donation.
研究组 & 干预措施
Oral iron sulphate (Duroferon®)
Oral iron sulphate (Duroferon®) is given to blood donors after blood donation
干预措施: Iron Sulfate (Drug)
Oral sucrosomial Iron (SiderAl Forte®)
Oral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation
干预措施: Sucrosomial Iron (Drug)
结局指标
主要结局
Side effects
时间窗: One year
The side effects are compared. At every visit the donors are asked to answer a questionary with questions about side effects. The amount and severity of the side effects will be compared between the two groups with different iron supplementations.
次要结局
- Iron balance(One Year)
- Symptoms(One year)
研究者
Karin Schneider
MD
Uppsala University Hospital