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

University of Lausanne (UNIL)

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency; Fatigue

Treatments: Drug: Ferrous sulphate; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00689793

Iron-0508-PMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Ferrous sulphate

2

Placebo Comparator group

Treatment:

Drug: Placebo