Evaluation of Iron Treatment Efficiency in Female Blood Donors With a Decreased Ferritin Level - Full Text View

Sponsor:	University of Lausanne
Collaborator:	Pierre Fabre Laboratories
Information provided by:	University of Lausanne
ClinicalTrials.gov Identifier:	NCT00689793

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 IV

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 in Female Blood Donors With a Decreased Ferritin Level: A Randomised Triple Blind Placebo Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Fatigue Iron

Drug Information available for: Ferrous sulfate Ferritin

U.S. FDA Resources

Further study details as provided by University of Lausanne:

Primary Outcome Measures:

Determine the level of fatigue at baseline and after one month of iron substitution, using a 10 point visual analogue scale and an other validated self administered questionnaire. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the ferritin and haemoglobin variation before and after donation and exposure. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Determine response of iron supplementation on mental disorder, quality of life and serious adverse events. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Determine response of iron substitution on aerobic capacity using an indirect measurement of VO2Max. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Measure adherence to treatment. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	134
Study Start Date:	November 2008
Estimated Study Completion Date:	April 2011
Estimated 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

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

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

Contacts

Contact: Bernard Favrat, MD PD	41-21-314-4906	bernard.favrat@chuv.ch
Contact: Sophie Waldvogel, MD	41-21-314-6586	sophiewaldvogel@mavietonsang.ch

Locations

Switzerland
Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne	Recruiting
Lausanne, Bugnon 44, Switzerland, 1011
Contact: Sophie Waldvogel, MD 41-21-314-6586 sophie.waldvogel@mavietonsang.ch
Contact: Baptiste Pedrazzini, MD baptiste.pedrazzini@chuv.ch
Principal Investigator: Bernard Favrat, MD PD
Sub-Investigator: Baptiste Pedrazzini, MD

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:

Verdon F, Burnand B, Stubi CL, Bonard C, Graff M, Michaud A, Bischoff T, de Vevey M, Studer JP, Herzig L, Chapuis C, Tissot J, Pécoud A, Favrat B. Iron supplementation for unexplained fatigue in non-anaemic women: double blind randomised placebo controlled trial. BMJ. 2003 May 24;326(7399):1124.

Patterson AJ, Brown WJ, Powers JR, Roberts DC. Iron deficiency, general health and fatigue: results from the Australian Longitudinal Study on Women's Health. Qual Life Res. 2000;9(5):491-7.

BEUTLER E, LARSH SE, GURNEY CW. Iron therapy in chronically fatigued, nonanemic women: a double-blind study. Ann Intern Med. 1960 Feb;52:378-94. No abstract available.

Bruner AB, Joffe A, Duggan AK, Casella JF, Brandt J. Randomised study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls. Lancet. 1996 Oct 12;348(9033):992-6.

Patterson AJ, Brown WJ, Roberts DC. Dietary and supplement treatment of iron deficiency results in improvements in general health and fatigue in Australian women of childbearing age. J Am Coll Nutr. 2001 Aug;20(4):337-42.

Newman BH, Roth AJ. Estimating the probability of a blood donation adverse event based on 1000 interviewed whole-blood donors. Transfusion. 2005 Nov;45(11):1715-21.

Newman B. Iron depletion by whole-blood donation harms menstruating females: the current whole-blood-collection paradigm needs to be changed. Transfusion. 2006 Oct;46(10):1667-81. Review. No abstract available.

Maghsudlu M, Nasizadeh S, Toogeh GR, Zandieh T, Parandoush S, Rezayani M. Short-term ferrous sulfate supplementation in female blood donors. Transfusion. 2008 Mar 17; [Epub ahead of print]

Magnussen K, Bork N, Asmussen L. The effect of a standardized protocol for iron supplementation to blood donors low in hemoglobin concentration. Transfusion. 2008 Apr;48(4):749-54. Epub 2008 Jan 8.

Kemna EH, Tjalsma H, Willems HL, Swinkels DW. Hepcidin: from discovery to differential diagnosis. Haematologica. 2008 Jan;93(1):90-7. Review.

Finberg KE, Heeney MM, Campagna DR, Aydinok Y, Pearson HA, Hartman KR, Mayo MM, Samuel SM, Strouse JJ, Markianos K, Andrews NC, Fleming MD. Mutations in TMPRSS6 cause iron-refractory iron deficiency anemia (IRIDA). Nat Genet. 2008 May;40(5):569-71. Epub 2008 Apr 13.

Brownlie T 4th, Utermohlen V, Hinton PS, Giordano C, Haas JD. Marginal iron deficiency without anemia impairs aerobic adaptation among previously untrained women. Am J Clin Nutr. 2002 Apr;75(4):734-42.

Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3.

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44.

Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8.

Janssen CA. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Eur J Obstet Gynecol Reprod Biol. 1996 Dec;70(1):21-2. Review. No abstract available.

Buckley JP, Sim J, Eston RG, Hession R, Fox R. Reliability and validity of measures taken during the Chester step test to predict aerobic power and to prescribe aerobic exercise. Br J Sports Med. 2004 Apr;38(2):197-205.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pedrazzini B, Waldvogel S, Cornuz J, Vaucher P, Bize R, Tissot JD, Pecoud A, Favrat B. The impact of iron supplementation efficiency in female blood donors with a decreased ferritin level and no anaemia. Rationale and design of a randomised controlled trial: a study protocol. Trials. 2009 Jan 16;10:4.

Responsible Party:	Bernard Favrat MD, Senior lecturer, Department of Ambulatory Care and Community Medicine, University of Lausanne
ClinicalTrials.gov Identifier:	NCT00689793 History of Changes
Other Study ID Numbers:	Iron-0508-PMU
Study First Received:	May 28, 2008
Last Updated:	June 25, 2010
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 February 09, 2012