Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial

Conditions
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Fatigue, Iron Deficiency

Intervention / Treatment
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* Drug: Ferrous sulphate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 18 - 50 eligible for a blood donation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Ferrous sulphate<br>* Volunteers will receive 80 mg/day oral ferrous sulphate (Tardyferon®) for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue ( Fatigue Severity Scale). We will also check depression and anxiety symptoms ( Prime MD ) and health survey ( SF-12 ). An evaluation of the menstruation ( Pictorial Bleeding Assessment Chart  of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.<br>* Other names: Iron deficiency;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Volunteers will receive 1 pill/day oral placebo for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue ( Fatigue Severity Scale). We will also check depression and anxiety symptoms ( Prime MD ) and health survey ( SF-12 ). An evaluation of the menstruation ( Pictorial Bleeding Assessment Chart  of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.<br>* Other names: Iron deficiency;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale. | 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. | baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Variation Before and After Treatment vs Placebo | The level of hemoglobin measured 4 weeks after randomization | baseline and 4 weeks | 
| Ferritin Change Before and After 4 Weeks of Treatment/Placebo | Level of ferritin measured 4 weeks after randomization | baseline and 4 weeks | 
| Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test | 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. | baseline and 4 weeks | 
| Response of Iron Supplementation on Mental Disorder | 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. | baseline and 4 weeks | 
| Adherence to Treatment. | 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) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Blood donation, Iron deficiency, Ferrous sulphate, Donation, Donors, Iron, Ferritin, Hemoglobin, Anemia, Anaemia, Haemoglobin, Don, Women blood donors