Clinical trial NCT00689793: Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors
Official title: Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fatigue
Iron Deficiency
Keywords: Fatigue
Blood donation
Iron deficiency
Ferrous sulphate
Donation
Donors
Iron
Ferritin
Hemoglobin
Anemia
Anaemia
Haemoglobin
Don
Women blood donors
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Laboratories
First posted: 2008-06-04
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Hemoglobin Variation Before and After Treatment vs Placebo
timeFrame: baseline and 4 weeks
measure: Ferritin Change Before and After 4 Weeks of Treatment/Placebo
timeFrame: baseline and 4 weeks
measure: Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test
timeFrame: baseline and 4 weeks
measure: Response of Iron Supplementation on Mental Disorder
timeFrame: baseline and 4 weeks
measure: Adherence to Treatment.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne
state: Bugnon 44
Study officials:
affiliation: Department of Amulatory Care and Community Medicine, University of Lausanne
name: Bernard Favrat, MD PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Amulatory Care and Community Medicine, University of Lausanne
name: Baptiste Pedrazzini, MD
role: STUDY_CHAIR
affiliation: Department of Amulatory Care and Community Medicine, University of Lausanne
name: Jacques Cornuz, Prof
role: STUDY_CHAIR
affiliation: Department of Amulatory Care and Community Medicine, University of Lausanne
name: Alain Pécoud, Prof
role: STUDY_CHAIR
affiliation: Blood Transfusion Department, University Hospitals of Lausanne
name: Sophie Waldvogel, MD
role: STUDY_CHAIR
affiliation: Blood Transfusion Department, University Hospitals of Lausanne
name: Jean-Daniel Tissot, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.