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

NCT00689793 | Completed Phase 4 Results DMC

• 1 other identifier: Iron-0508-PMU
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Iron Deficiency

Keywords

Fatigue; Blood donation; Iron deficiency; Ferrous sulphate; Donation; Donors; Iron; Ferritin; Hemoglobin; Anemia; Anaemia; Haemoglobin; Don; Women blood donors

Outcome Measures

Primary Outcomes (1)

• Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.

  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 Outcomes (5)

• Hemoglobin Variation Before and After Treatment vs Placebo

  baseline and 4 weeks

• Ferritin Change Before and After 4 Weeks of Treatment/Placebo

  baseline and 4 weeks

• Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test

  baseline and 4 weeks

• Response of Iron Supplementation on Mental Disorder

  baseline and 4 weeks

• Adherence to Treatment.

  4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Ferrous sulphate

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ferrous sulphate DRUG

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.

Also known as: Iron treatment, Ferrous sulphate treatment, Tardyferon, Robapharm, Fer, Sulphate de fer, Sulphate ferreux, Iron deficiency

1

Placebo DRUG

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.

Also known as: Iron treatment, Ferrous sulphate treatment, Tardyferon, Robapharm, Fer, Sulphate de fer, Sulphate ferreux, Iron deficiency

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women
• aged 18 - 50
• eligible for a blood donation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne: lead
• Pierre Fabre Laboratories: collaborator

Study Sites (1)

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

Lausanne, Bugnon 44, 1011, Switzerland

Location

Related Publications (17)

• 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, Pecoud 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. doi: 10.1136/bmj.326.7399.1124.

  PMID: 12763985 BACKGROUND

• 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. doi: 10.1023/a:1008978114650.

  PMID: 11190004 BACKGROUND

• 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. doi: 10.7326/0003-4819-52-2-378. No abstract available.

  PMID: 13800263 BACKGROUND

• 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. doi: 10.1016/S0140-6736(96)02341-0.

  PMID: 8855856 BACKGROUND

• 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. doi: 10.1080/07315724.2001.10719054.

  PMID: 11506061 BACKGROUND

• 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. doi: 10.1111/j.1537-2995.2005.00595.x.

  PMID: 16271095 BACKGROUND

• 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. doi: 10.1111/j.1537-2995.2006.00969.x. No abstract available.

  PMID: 17002622 BACKGROUND

• Maghsudlu M, Nasizadeh S, Toogeh GR, Zandieh T, Parandoush S, Rezayani M. Short-term ferrous sulfate supplementation in female blood donors. Transfusion. 2008 Jun;48(6):1192-7. doi: 10.1111/j.1537-2995.2007.01671.x. Epub 2008 Mar 17.

  PMID: 18363581 BACKGROUND

• 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. doi: 10.1111/j.1537-2995.2007.01601.x. Epub 2008 Jan 8.

  PMID: 18194390 BACKGROUND

• 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. doi: 10.1093/ajcn/75.4.734.

  PMID: 11916761 BACKGROUND

• 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. doi: 10.1001/archneur.1989.00520460115022.

  PMID: 2803071 BACKGROUND

• 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. doi: 10.1001/jama.282.18.1737.

  PMID: 10568646 BACKGROUND

• 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. doi: 10.1016/s0895-4356(98)00109-7.

  PMID: 9817135 BACKGROUND

• 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. doi: 10.1016/s0301-2115(96)02570-5. No abstract available.

  PMID: 9031914 BACKGROUND

• 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. doi: 10.1136/bjsm.2003.005389.

  PMID: 15039259 BACKGROUND

• 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. doi: 10.1186/1741-7015-10-8.

  PMID: 22272750 RESULT

• 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. doi: 10.1186/1745-6215-10-4.

  PMID: 19149890 DERIVED

MeSH Terms

Conditions

Fatigue; Iron Deficiencies; Anemia

Interventions

ferrous sulfate; ferrous sulfate, mucin drug combination; Iron, Dietary

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Iron Compounds; Inorganic Chemicals

Results Point of Contact

• Title: Dr Bernard Favrat MD
• Organization: Departement of ambulatory care and community medicine, University of Lausanne, Switzerland

Bernard.favrat@chuv.ch

+41795566183314

Study Officials

• Bernard Favrat, MD PD

  Department of Amulatory Care and Community Medicine, University of Lausanne

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 4, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 15, 2013
• Results First Posted: February 15, 2013

Record last verified: 2013-01

Locations

CH (1)