Single Center Clinical Trial to Evaluate the Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Increase of serum ferritin concentration under iron supplementation
研究概览
简要总结
Iron deficiency is common in Switzerland and the main reason for anaemia. Nearly one in five premenopausal women suffers from iron deficiency. Low iron intake, reduced iron resorption or loss of blood are the main cause for iron deficiency. Symptoms of iron deficiency, for example fatigue, weakness, headache or exercise intolerance are primarily due to anaemia, but the same symptoms may also be present in non-anaemic patients with low serum ferritin. Consequently it is important to detect and treat non-anaemic iron deficiency. Common side effects of oral iron supplementation are primarily gastrointestinal symptoms like nausea, vomiting, diarrhea or abdominal pain. There is a positive correlation between appearance of gastrointestinal symptoms and administered iron dose. To date, only few studies have investigated effectiveness of low-dose iron supplementation in different target groups. The aim of this study is to investigate if low dose iron supplementation with 12mg iron per day for 8 weeks is sufficient to increase serum ferritin levels into a normal range in healthy premenopausal women suffering from non-anaemic iron deficiency
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Female gender
- •Premenopausal
- •Age > 18 years
- •Regular menstrual cycle
- •BMI in normal range (18-25 kg/m²)
- •Serum-ferritin <30ng/ml
- •No anaemia
- •symptomatic iron deficiency in the past
- •No intake of dietary supplements
- •Exclusion Criteria
- •Intake of dietary supplements
- •Pregnancy
- •Hypermenorrhea
- •Serum-ferritin >30ng/ml
- •BMI <18 kg/m² or >25 kg/m²
- •chronic inflammatory diseases (e.g. colitis)
- •Hypersensitivity to iron-supplements
- •psychiatric disorder
排除标准
- 未提供
结局指标
主要结局
Increase of serum ferritin concentration under iron supplementation
时间窗: 8 weeks
significant increase of serum-ferritin concentration after 8 weeks of low-dose iron-supplementation
次要结局
- Side-effects of treatment(8 weeks)
- Serum hepcidin concentration(8 weeks)
研究者
Pierre-Alexandre Krayenbuehl
Clinical Professor
University of Zurich
