AzTrials
AzTrials

Iron DeficiencyPhase 3IronWoManNCT01787526

Intravenous High Dose Iron in Blood Donors

A Phase 3 study testing ferric carboxymaltose and oral iron in people with Iron Deficiency, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

2-3% of the population participates in blood donation programmes. Traditionally, safety issues in transfusion medicine have been concentrating on product and recipient safety. Extensive efforts including strict donor inclusion criteria and testing for important transmissible infections have substantially improved… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Iron Deficiency
What is being tested?
ferric carboxymaltose and oral iron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteAustria
Study dates
Jun 2014to Aug 2016
Phase
Phase 3
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age ≥18 years and ≤ 65 years
  • ferritin ≤ 30 ng/ml
  • fulfilment of the strict criteria for blood donation

Who cannot join

  • hemochromatosis
  • active infection
  • pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Graz

    Graz, 8036

Other trials in Austria

About this study

Official title: High Dose Intravenous Iron in Blood Donors With Iron Deficiency: a Randomized, Controlled Trial

2-3% of the population participates in blood donation programmes. Traditionally, safety issues in transfusion medicine have been concentrating on product and recipient safety. Extensive efforts including strict donor inclusion criteria and testing for important transmissible infections have substantially improved product quality. One of the most common risks of blood donation is iatrogenic iron deficiency. It may affect up to 30% of regular blood donors because each whole blood donation causes a loss of 200 to 250 mg of iron. Although this has been known for at least 50 years, iron deficiency is not routinely assessed or treated in this population. Contributing factors include donation frequency, lower weight and female gender. Women have lower iron reserves and in premenopausal women, the daily required amount of iron is higher than in men. Besides anemia, iron deficiency may lead to fatigue and impaired cognitive and physical performance. Oral iron substitution is often associated with significant gastrointestinal side effects leading to poor compliance. Today, intravenous (iv.) iron preparations are well tolerated and allow the application of a large dose of 1000mg in one visit. Our hypothesis is that in blood donors with iron deficiency intravenous iron is feasible and preferable to oral iron because of its high efficacy and optimal compliance with a similar safety profile that has been extensively studied in other populations than blood donors.

Read the detailed description

Iron deficiency is possibly the most prevalent worldwide nutritive deficiency and it has been estimated that > 500 million people have adverse effects as a result. Total body iron amounts to 3 to 4.5 grams, the largest part being bound to hemoglobin in red cells.

One of the most common risks of blood donation is iatrogenic iron deficiency which may affect up to 30% of regular blood donors. Each whole blood donation means a whole blood loss of 450 ml ±10% for the bag and additional samples for the required tests, corresponding to a loss of 200 to 300 mg of iron. It has been estimated that 10 apheresis donations equal 1 whole blood donation. Contributing factors include donation frequency, low body weight and female gender. In Austria, the maximal annual donation frequency is 50x for plasmapheresis, 26x for plateletpheresis and 4 (women) respectively 6x (men) for whole blood donations. Although the frequent donation-induced development of iron depletion has been recognized for at least 50 years, iron deficiency is not routinely assessed or treated in this population. Recently it was reported that the presence of pica, the bizarre consumption of nonnutritive substances such as ice cubes, is associated with a high probability of iron depletion in blood donors.

Contributing factors to a poor iron status in blood donors include donation frequency, lower weight and female gender. Women also have lower iron reserves and in premenopausal women, the daily required amount of iron is higher than in men. Besides anemia, iron deficiency may lead to fatigue and impaired cognitive and physical performance. Several trials have evaluated different regimens of iron substitution in blood donors and demonstrated good treatment compliance and efficacy in improving iron status. Oral iron substitution is often associated with significant gastrointestinal side effects leading to poor compliance. Today, high-dose intravenous (iv.) iron preparations are available, well tolerated and allow for the application of a large dose of 1000mg in one visit.

Conditions
Iron Deficiency
Being tested
ferric carboxymaltose, oral iron
Keywords
iron depletion, donor safety, blood donation, transfusion medicine, iron deficiency, intravenous iron, fatigue, restless legs syndrome, anemia
Medical subject headings
Iron Deficiencies, Fatigue, Restless Legs Syndrome, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ferric carboxymaltoseDrug

    Also called ferinject

    1 g intravenously per infusion

  • oral ironDrug

    Also called Ferretab

    oral tablets of 100mg iron over 8 weeks, total dose 10g

Study groups in NCT01787526
Study groupRoleWhat they receive
Oral IronActive comparatororal iron in a corresponding dose of 10g (assuming an absorption of 10%, 100 capsules a 100mg iron each) taken over 8-12 weeks
Receives: Drug: oral iron
Intravenous high dose ironExperimentalhigh dose intravenous iron (ferric carboxymaltose, 1000mg)
Receives: Drug: ferric carboxymaltose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. transferrin saturation (%) at visit 1 (V1)

    Measured: 8 weeks

Secondary outcomes (1)

  1. Number of patients with adverse events of different grades

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01787526
Sponsor's protocol ID
1.0
Other IDs
2013-000327-14
Acronym
IronWoMan
Status last verified
Oct 2016
First submitted
6 Feb 2013
Last updated
6 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Amrein K, Valentin A, Lanzer G, Drexler C. Adverse events and safety issues in blood donation--a comprehensive review. Blood Rev. 2012 Jan;26(1):33-42. doi: 10.1016/j.blre.2011.09.003. Epub 2011 Oct 11.

    PubMed 21996651

  • Semmelrock MJ, Raggam RB, Amrein K, Avian A, Schallmoser K, Lanzer G, Semmelrock HJ, Prueller F, Berghold A, Rohde E. Reticulocyte hemoglobin content allows early and reliable detection of functional iron deficiency in blood donors. Clin Chim Acta. 2012 Apr 11;413(7-8):678-82. doi: 10.1016/j.cca.2011.12.006. Epub 2011 Dec 23.

    PubMed 22212625

  • 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.

    PubMed 17002622

  • Cable RG, Glynn SA, Kiss JE, Mast AE, Steele WR, Murphy EL, Wright DJ, Sacher RA, Gottschall JL, Tobler LH, Simon TL; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2012 Apr;52(4):702-11. doi: 10.1111/j.1537-2995.2011.03401.x. Epub 2011 Oct 24.

    PubMed 22023513

  • Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61. doi: 10.1111/j.1537-2995.2011.03062.x. No abstract available.

    PubMed 21388389

  • Bianco C, Brittenham G, Gilcher RO, Gordeuk VR, Kushner JP, Sayers M, Chambers L, Counts RB, Aylesworth C, Nemo G, Alving B. Maintaining iron balance in women blood donors of childbearing age: summary of a workshop. Transfusion. 2002 Jun;42(6):798-805. doi: 10.1046/j.1537-2995.2002.00103.x. No abstract available.

    PubMed 12147035

  • BAST G, PEISKER H, SCHUMANN HD. [Latent disorders caused by iron deficiency in frequent blood donors]. Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1956;283(3):280-90. No abstract available. German.

    PubMed 13386295

  • Moore RA, Gaskell H, Rose P, Allan J. Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data. BMC Blood Disord. 2011 Sep 24;11:4. doi: 10.1186/1471-2326-11-4.

    PubMed 21942989

  • Birgegard G, Schneider K, Ulfberg J. High incidence of iron depletion and restless leg syndrome (RLS) in regular blood donors: intravenous iron sucrose substitution more effective than oral iron. Vox Sang. 2010 Nov;99(4):354-61. doi: 10.1111/j.1423-0410.2010.01368.x.

    PubMed 20598107

  • Macher S, Herster C, Holter M, Moritz M, Matzhold EM, Stojakovic T, Pieber TR, Schlenke P, Drexler C, Amrein K. The Effect of Parenteral or Oral Iron Supplementation on Fatigue, Sleep, Quality of Life and Restless Legs Syndrome in Iron-Deficient Blood Donors: A Secondary Analysis of the IronWoMan RCT. Nutrients. 2020 May 5;12(5):1313. doi: 10.3390/nu12051313.

    PubMed 32380660

  • Drexler C, Macher S, Lindenau I, Holter M, Moritz M, Stojakovic T, Pieber TR, Schlenke P, Amrein K. High-dose intravenous versus oral iron in blood donors with iron deficiency: The IronWoMan randomized, controlled clinical trial. Clin Nutr. 2020 Mar;39(3):737-745. doi: 10.1016/j.clnu.2019.03.025. Epub 2019 Mar 26.

    PubMed 30981629

  • Macher S, Drexler C, Lindenau I, Sareban N, Schlenke P, Amrein K. High-dose intravenously administered iron versus orally administered iron in blood donors with iron deficiency: study protocol for a randomised, controlled trial. Trials. 2016 Oct 28;17(1):527. doi: 10.1186/s13063-016-1648-y.

    PubMed 27793204

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ferric carboxymaltose and oral iron in people with Iron Deficiency, run by Medical University of Graz at 1 site in Austria.

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 3 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 6 Oct 2016. 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 Austria. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

transferrin saturation (%) at visit 1 (V1) (time frame: 8 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 NCT01787526, which also lists 12 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 6 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in