Optimizing Dosing Strategies in Oral Iron Supplementation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change of Hemoglobin after 12 weeks
研究概览
简要总结
The goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency.
The main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose.
Participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Informed Consent signed by the subject
- •≥18 years of age
- •Iron deficiency: Ferritin <30 µg/l
- •hemoglobin ≥ 80 g/l
- •CRP < 5 mg/l
排除标准
- •Refusal of study participation,
- •Regular administration of Erythropoietin
- •Oral or intravenous iron supplementation <12 weeks prior to investigation
- •Contraindications to intervention medication (Tardyferon), e.g. known hypersensitivity or allergy to iron sulfate / ferrous sulfate
- •Blood transfusion or donation <12 weeks prior to investigation
- •Active chemotherapy
- •Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.
- •Due to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (MM/DD/YYYY):
- •Anemia (as defined by the WHO): Hemoglobin <130 g/L for men, Hemoglobin <120 g/l for women, Hemoglobin <110 g/l for pregnant women
研究组 & 干预措施
Intervention Group
Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks.
干预措施: Tardyferon (Drug)
Active Control
Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks
干预措施: Tardyferon (Drug)
结局指标
主要结局
Change of Hemoglobin after 12 weeks
时间窗: 12 weeks
Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation
次要结局
- Proportion of participants achieving treatment goal(12 weeks)
- Change of iron parameters from baseline(12 weeks)
- Side effects(12 weeks)
研究者
Helene Meyer
Principal Investigator
Luzerner Kantonsspital