Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
研究概览
简要总结
The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin < 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.
详细描述
- Actually, there's no recommendation to check ferritin level in blood donors, even if several studies pointed out the high prevalence of iron deficiency after a blood donation. Furthermore, some clinical trials showed that non-anaemic women with unexplained fatigue may benefit from iron supplementation.
- The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin < 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.
- We will measure blood count, ferritin level and C-reactive protein at the time of the blood donation and then after a week, a month and 3 months.
A week after the blood donation, donors with a ferritin level <30 ng/ml and hemoglobin > 120g/l (non anaemic) will be included in the study and randomised. A one-month iron treatment vs placebo will be introduced. To assess the subjective response on fatigue, the donors will fill in different questionnaires at the time of the blood donation and then after a week, a month and 3 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 18 - 50
- •eligible for a blood donation
排除标准
- •age below 18 or above 50
- •not eligible for a blood donation (according to the blood donation eligibility guidelines of the Swiss Red Cross)
- •hemochromatosis, psychiatric / thyroid / hepatic / rheumatismal / kidney or cardiopulmonary diseases that can cause fatigue
- •intestinal disease or medical treatment that can perturb iron absorption and/or excretion
- •donors with mental disorder or psychiatric disease that are unable to give consent
- •acute or chronic inflammation
- •diabetes and pregnancy
研究组 & 干预措施
1
干预措施: Ferrous sulphate (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
时间窗: baseline and 4 weeks
The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from "no fatigue=0" to "very severe fatigue=10".
次要结局
- Hemoglobin Variation Before and After Treatment vs Placebo(baseline and 4 weeks)
- Ferritin Change Before and After 4 Weeks of Treatment/Placebo(baseline and 4 weeks)
- Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test(baseline and 4 weeks)
- Response of Iron Supplementation on Mental Disorder(baseline and 4 weeks)
- Adherence to Treatment.(4 weeks)
研究者
Bernard Favrat
MD
University of Lausanne