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

January 15, 2013 updated by: Bernard Favrat, University of Lausanne

Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Bugnon 44
      • Lausanne, Bugnon 44, Switzerland, 1011
        • Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
Time Frame: baseline and 4 weeks
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".
baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Variation Before and After Treatment vs Placebo
Time Frame: baseline and 4 weeks
The level of hemoglobin measured 4 weeks after randomization
baseline and 4 weeks
Ferritin Change Before and After 4 Weeks of Treatment/Placebo
Time Frame: baseline and 4 weeks
Level of ferritin measured 4 weeks after randomization
baseline and 4 weeks
Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test
Time Frame: baseline and 4 weeks
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.
baseline and 4 weeks
Response of Iron Supplementation on Mental Disorder
Time Frame: baseline and 4 weeks
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.
baseline and 4 weeks
Adherence to Treatment.
Time Frame: 4 weeks
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)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iron-0508-PMU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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