ISRCTN78430425已完成不适用
Effect of intravenous iron versus placebo on exhaustion symptoms in non-anaemic premenopausal women with low ferritin levels
Vifor Pharma, Vifor (International) Ltd (Switzerland)0 个研究点目标入组 100 人开始时间: 2010年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Premenopausal, regularly menstruating women
- •2. Age = 18 years
- •3. S-ferretin < 50ng/mL
- •4. Signed informed consent
- •5. Reduced physical and mental performance (fatigue, depressive mood, dizziness, sleep disturbance, concentration, neck pain, headache) as determined by investigator
- •6. Adequate contraception
排除标准
- •1. Haemoglobin (Hb) level 120 g/L
- •2. Known mental and physical disorder (cancer, depression)
- •3. Use of concomitant medication to cause symptoms of fatigue and depression (antidepressive & chemotherapeutic agents, sedatives)
- •4. Use of iron preparations within previous 4-weeks
- •5. Active sever infection, inflammation, malignancy
- •6. C-Reactive Protein (CRP) > 20 mg/mL
- •7. Thyroid-Stimulating Hormone (TSH) > 4 micro U/mL
- •8. Use of menstruation depressing gestagens
- •9. History of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
- •10. Significant cardiovascular disease e.g. unstable angina, New York Heart Association (NYHA) class IV
- •11. Hypersensitivity to iron sucrose or iron sulphate
- •12. Pregnancy or lactation
- •13. Participation in any other therapeutic study in the previous month
研究者
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