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

This study has been completed.
Sponsor:
Collaborator:
Pierre Fabre Laboratories
Information provided by (Responsible Party):
Bernard Favrat, University of Lausanne
ClinicalTrials.gov Identifier:
NCT00689793
First received: May 28, 2008
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Fatigue
Iron Deficiency
Drug: Ferrous sulphate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale. [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • Hemoglobin Variation Before and After Treatment vs Placebo [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The level of hemoglobin measured 4 weeks after randomization

  • Ferritin Change Before and After 4 Weeks of Treatment/Placebo [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    Level of ferritin measured 4 weeks after randomization

  • Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Response of Iron Supplementation on Mental Disorder [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Adherence to Treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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)


Enrollment: 154
Study Start Date: November 2008
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Other Names:
  • Iron treatment
  • Ferrous sulphate treatment
  • Tardyferon
  • Robapharm
  • Fer
  • Sulphate de fer
  • Sulphate ferreux
  • Iron deficiency
Placebo Comparator: 2 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.
Other Names:
  • Iron treatment
  • Ferrous sulphate treatment
  • Tardyferon
  • Robapharm
  • Fer
  • Sulphate de fer
  • Sulphate ferreux
  • Iron deficiency

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689793

Locations
Switzerland
Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne
Lausanne, Bugnon 44, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne
Pierre Fabre Laboratories
Investigators
Principal Investigator: Bernard Favrat, MD PD Department of Amulatory Care and Community Medicine, University of Lausanne
Study Chair: Baptiste Pedrazzini, MD Department of Amulatory Care and Community Medicine, University of Lausanne
Study Chair: Jacques Cornuz, Prof Department of Amulatory Care and Community Medicine, University of Lausanne
Study Chair: Alain Pécoud, Prof Department of Amulatory Care and Community Medicine, University of Lausanne
Study Chair: Sophie Waldvogel, MD Blood Transfusion Department, University Hospitals of Lausanne
Study Chair: Jean-Daniel Tissot, Prof Blood Transfusion Department, University Hospitals of Lausanne
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernard Favrat, MD, University of Lausanne
ClinicalTrials.gov Identifier: NCT00689793     History of Changes
Other Study ID Numbers: Iron-0508-PMU
Study First Received: May 28, 2008
Results First Received: May 18, 2012
Last Updated: January 15, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University of Lausanne:
Fatigue
Blood donation
Iron deficiency
Ferrous sulphate
Donation
Donors
Iron
Ferritin
Hemoglobin
Anemia
Anaemia
Haemoglobin
Don
Women blood donors

Additional relevant MeSH terms:
Fatigue
Anemia, Iron-Deficiency
Signs and Symptoms
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014