Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors
- Registration Number
- NCT00689793
- Lead Sponsor
- University of Lausanne
- Brief Summary
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.
- Detailed Description
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 154
- women
- aged 18 - 50
- eligible for a blood donation
- men
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 Ferrous sulphate -
- Primary Outcome Measures
Name Time Method Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale. 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".
- Secondary Outcome Measures
Name Time Method Hemoglobin Variation Before and After Treatment vs Placebo baseline and 4 weeks The level of hemoglobin measured 4 weeks after randomization
Ferritin Change Before and After 4 Weeks of Treatment/Placebo baseline and 4 weeks Level of ferritin measured 4 weeks after randomization
Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test baseline and 4 weeks Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.
Response of Iron Supplementation on Mental Disorder baseline and 4 weeks Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score \>15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or \<15) after placebo or treatment.
Adherence to Treatment. 4 weeks Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)
Trial Locations
- Locations (1)
Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne
🇨🇭Lausanne, Bugnon 44, Switzerland