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

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.

Conditions

• Fatigue
• Iron Deficiency

Interventions

DRUG

Ferrous sulphate

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• Pierre Fabre Laboratories

  collaborator INDUSTRY

• University of Lausanne

  lead OTHER

Principal Investigators

• Bernard Favrat, MD PD · Department of Amulatory Care and Community Medicine, University of Lausanne

• Baptiste Pedrazzini, MD · Department of Amulatory Care and Community Medicine, University of Lausanne

• Jacques Cornuz, Prof · Department of Amulatory Care and Community Medicine, University of Lausanne

• Alain Pécoud, Prof · Department of Amulatory Care and Community Medicine, University of Lausanne

• Sophie Waldvogel, MD · Blood Transfusion Department, University Hospitals of Lausanne

• Jean-Daniel Tissot, Prof · Blood Transfusion Department, University Hospitals of Lausanne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2010-10-31

Completion

2011-04-30

Countries

• Switzerland

Study Locations