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| Name | Class |
|---|---|
| Pierre Fabre Laboratories | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Variation Before and After Treatment vs Placebo | The level of hemoglobin measured 4 weeks after randomization | baseline and 4 weeks |
| Ferritin Change Before and After 4 Weeks of Treatment/Placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne | Lausanne | Bugnon 44 | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12763985 | Background | 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. | |
| 11190004 |
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One week after whole blood donation, participants were randomized if they were not anemic and their ferritin level was < or = 30 ng/mL.
Premopausal female blood donors coming spontaneously to the donation center, were asked to participated to this study. After agreement an informed consent was signed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Treatment of Iron | One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month. |
| FG001 | Placebo | One week after donation, donors self-administered on pill of placebo (daily), during one month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Treatment of Iron | One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month. |
| BG001 | Placebo | One week after donation, donors self-administered on pill of placebo (daily), during one month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | The sample size for randomized volunteers was calculated using a two-sample comparison of means to detect a one point difference in the visual analogical scale (first outcome). | Posted | Mean | Standard Deviation | centimeter | baseline and 4 weeks |
|
adverse events were reported during the 4 weeks of treatment/placebo
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Treatment of Iron | One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastro-intestinal events | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Bernard Favrat MD | Departement of ambulatory care and community medicine, University of Lausanne, Switzerland | +41795566183314 | Bernard.favrat@chuv.ch |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| C009380 | ferrous sulfate, mucin drug combination |
| D019266 | Iron, Dietary |
| ID | Term |
|---|---|
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| 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. |
|
|
Level of ferritin measured 4 weeks after randomization
| baseline and 4 weeks |
| Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test | 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 | 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. | 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 |
| 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. |
| 13800263 | 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. |
| 8855856 | 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. |
| 11506061 | 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. |
| 16271095 | 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. |
| 17002622 | 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. |
| 18363581 | 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. |
| 18194390 | 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. |
| 11916761 | 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. |
| 2803071 | 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. |
| 10568646 | 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. |
| 9817135 | 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. |
| 9031914 | 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. |
| 15039259 | 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. |
| 22272750 | Result | 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. |
| 19149890 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
|
|
|
| Secondary | Hemoglobin Variation Before and After Treatment vs Placebo | The level of hemoglobin measured 4 weeks after randomization | The number of participants was calculated according to the primary outcome. | Posted | Mean | Standard Deviation | g/L | baseline and 4 weeks |
|
|
|
|
| Secondary | Ferritin Change Before and After 4 Weeks of Treatment/Placebo | Level of ferritin measured 4 weeks after randomization | Posted | Mean | Standard Deviation | ng/mL | baseline and 4 weeks |
|
|
|
|
| Secondary | Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test | 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. | Posted | Mean | Standard Deviation | mLO2/kg/min | baseline and 4 weeks |
|
|
|
|
| Secondary | Response of Iron Supplementation on Mental Disorder | 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. | Number of participant was set according the primary outcome. | Posted | Number | participants | baseline and 4 weeks |
|
|
|
| Secondary | Adherence to Treatment. | 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) | Posted | Mean | Standard Deviation | percentage of day | 4 weeks |
|
|
|
| 0 |
| 74 |
| 29 |
| 74 |
| EG001 | Placebo | One week after donation, donors self-administered on pill of placebo (daily), during one month. | 0 | 71 | 11 | 71 |
| other events (not serious) | General disorders | Systematic Assessment | dizziness (n=3), headache (n=2), acne (n=2), palpitations (n=1), and renal lithiasis (n=1) |
|
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| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |