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临床试验/NCT04636060
NCT04636060已完成不适用

Single Center Clinical Trial to Evaluate the Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women

University of Zurich2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre-Alexandre Krayenbuehl

Clinical Professor

University of Zurich

研究点 (2)

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