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

PHASE4CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

October 31, 2010

Study Completion Date

April 30, 2011

Conditions
FatigueIron 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."

Trial Locations (1)

1011

Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne, Lausanne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pierre Fabre Laboratories

INDUSTRY

lead

University of Lausanne

OTHER