FatiguePhase 4ferdonNCT00689793
Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors
A Phase 4 study testing Ferrous sulphate in people with Fatigue and Iron Deficiency, run by University of Lausanne at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Iron Deficiency
- What is being tested?
- Ferrous sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2008to Apr 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- aged 18 - 50
- eligible for a blood donation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne
Lausanne, Bugnon 44, 1011
About this study
Official title: Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Fatigue, Iron Deficiency
- Being tested
- Ferrous sulphate, Placebo
- Keywords
- Fatigue, Blood donation, Iron deficiency, Ferrous sulphate, Donation, Donors, Iron, Ferritin, Hemoglobin, Anemia, Anaemia, Haemoglobin, Don, Women blood donors
- Medical subject headings
- Fatigue, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulphateDrug
Also called Iron treatment, Ferrous sulphate treatment, Tardyferon, Robapharm
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.
PlaceboDrug
Also called Iron treatment, Ferrous sulphate treatment, Tardyferon, Robapharm
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Ferrous sulphate |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: baseline and 4 weeks
Secondary outcomes (5)
Hemoglobin Variation Before and After Treatment vs Placebo
The level of hemoglobin measured 4 weeks after randomization
Measured: baseline and 4 weeks
Ferritin Change Before and After 4 Weeks of Treatment/Placebo
Level of ferritin measured 4 weeks after randomization
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Responsible party
- Principal investigator, Bernard Favrat, University of Lausanne
- Investigators
- Bernard Favrat, MD PD, Principal investigator, Department of Amulatory Care and Community Medicine, University of LausanneBaptiste Pedrazzini, MD, Study chair, Department of Amulatory Care and Community Medicine, University of LausanneJacques Cornuz, Prof, Study chair, Department of Amulatory Care and Community Medicine, University of LausanneAlain Pécoud, Prof, Study chair, Department of Amulatory Care and Community Medicine, University of LausanneSophie Waldvogel, MD, Study chair, Blood Transfusion Department, University Hospitals of LausanneJean-Daniel Tissot, Prof, Study chair, Blood Transfusion Department, University Hospitals of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689793
- Sponsor's protocol ID
- Iron-0508-PMU
- Acronym
- ferdon
- Status last verified
- Jan 2013
- First submitted
- 28 May 2008
- Last updated
- 15 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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, 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.
PubMed 12763985Patterson 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.
PubMed 11190004BEUTLER 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.
PubMed 13800263Bruner 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.
PubMed 8855856Patterson 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.
PubMed 11506061Newman 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.
PubMed 16271095Newman 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.
PubMed 17002622Maghsudlu 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.
PubMed 18363581Magnussen 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.
PubMed 18194390Brownlie 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.
PubMed 11916761Krupp 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.
PubMed 2803071Spitzer 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.
PubMed 10568646Gandek 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.
PubMed 9817135Janssen 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.
PubMed 9031914Buckley 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.
PubMed 15039259
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00689793
- Acronym / sponsor ID
- ferdon / Iron-0508-PMU
- Conditions
- Fatigue, Iron Deficiency
- Keywords
- Fatigue, Blood donation, Iron deficiency, Ferrous sulphate, Donation, Donors, Iron, Ferritin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Posted 15 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ferrous sulphate |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women
- aged 18 - 50
- eligible for a blood donation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulphateAlso: Iron treatment, Ferrous sulphate treatment, Tardyferon, RobapharmVolunteers 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. | Drug | 1 |
| PlaceboAlso: Iron treatment, Ferrous sulphate treatment, Tardyferon, RobapharmVolunteers 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. | Drug | 2 |
Primary outcome
Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
Time frame: baseline and 4 weeks
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".
5 secondary outcomes
Hemoglobin Variation Before and After Treatment vs Placebo
Time frame: baseline and 4 weeks
Ferritin Change Before and After 4 Weeks of Treatment/Placebo
Time frame: baseline and 4 weeks
Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test
Time frame: baseline and 4 weeks
Response of Iron Supplementation on Mental Disorder
Time frame: baseline and 4 weeks
Adherence to Treatment.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12763985Verdon 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.
- Background: PubMed 11190004Patterson 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.
- Background: PubMed 13800263BEUTLER 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.
- Background: PubMed 8855856Bruner 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.
- Background: PubMed 11506061Patterson 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.
- Background: PubMed 16271095Newman 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.
- Background: PubMed 17002622Newman 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.
- Background: PubMed 18363581Maghsudlu 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.
- Background: PubMed 18194390Magnussen 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.
- Background: PubMed 11916761Brownlie 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.
- Background: PubMed 2803071Krupp 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.
- Background: PubMed 10568646Spitzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Favrat, MD PD principal investigator
Department of Amulatory Care and Community Medicine, University of Lausanne
Baptiste Pedrazzini, MD study chair
Department of Amulatory Care and Community Medicine, University of Lausanne
Jacques Cornuz, Prof study chair
Department of Amulatory Care and Community Medicine, University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous sulphate in people with Fatigue and Iron Deficiency, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale. (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00689793, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.