Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors
Condition: Fatigue; Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies; Fatigue
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Ferrous sulphate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Iron treatment; Ferrous sulphate treatment; Tardyferon; Robapharm; Fer; Sulphate de fer; Sulphate ferreux; Iron deficiency; Iron treatment; Ferrous sulphate treatment; Tardyferon; Robapharm; Fer; Sulphate de fer; Sulphate ferreux; Iron deficiency
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatigue; Blood donation; Iron deficiency; Ferrous sulphate; Donation; Donors; Iron; Ferritin; Hemoglobin; Anemia; Anaemia; Haemoglobin; Don; Women blood donors