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

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:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Fatigue Iron

Drug Information available for: Ferrous sulfate Ferrous sulfate heptahydrate Sulfate ion

U.S. FDA Resources

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

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

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:

Waldvogel S, Pedrazzini B, Vaucher P, Bize R, Cornuz J, Tissot JD, Favrat B. Clinical evaluation of iron treatment efficiency among non-anemic but iron-deficient female blood donors: a randomized controlled trial. BMC Med. 2012 Jan 24;10:8.

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.

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, 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 June 18, 2013

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