- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787526
Intravenous High Dose Iron in Blood Donors (IronWoMan)
High Dose Intravenous Iron in Blood Donors With Iron Deficiency: a Randomized, Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Graz, Austria, 8036
- Medical University of Graz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age ≥18 years and ≤ 65 years
- ferritin ≤ 30 ng/ml
- fulfilment of the strict criteria for blood donation
Exclusion Criteria:
- hemochromatosis
- active infection
- pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oral Iron
oral iron in a corresponding dose of 10g (assuming an absorption of 10%, 100 capsules a 100mg iron each) taken over 8-12 weeks
|
oral tablets of 100mg iron over 8 weeks, total dose 10g
Other Names:
|
Experimental: Intravenous high dose iron
high dose intravenous iron (ferric carboxymaltose, 1000mg)
|
1 g intravenously per infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
transferrin saturation (%) at visit 1 (V1)
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events of different grades
Time Frame: 8 weeks
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Other parameters of iron metabolism and red blood count
Time Frame: 8 weeks
|
8 weeks
|
Subjective symptoms fatigue
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karin Amrein, MD, Medical University Graz, Austria
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.0
- 2013-000327-14 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Deficiency
-
Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
-
Swiss Federal Institute of TechnologyUniversity of MalawiCompletedIron-deficiency | Iron Deficiency AnemiaMalawi, Switzerland
-
Johann Wolfgang Goethe University HospitalLudwig-Maximilians - University of MunichCompletedNon-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IXIron-deficiency | Anemia | Iron Deficiency AnemiaGermany
-
Kansas State UniversityUnited States Department of Agriculture Foreign Agricultural Service; American...CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
Clinical Trials on oral iron
-
GWT-TUD GmbHShield TherapeuticsCompleted
-
Sanjay Gandhi Postgraduate Institute of Medical...Completed
-
University of PecsNot yet recruitingAnemia | GastroIntestinal BleedingHungary
-
American University of Beirut Medical CenterPharma M SAL, LebanonRecruitingUlcerative Colitis | Anemia, Iron DeficiencyLebanon
-
NICHD Global Network for Women's and Children's...Boston University; University of Colorado, Denver; University of Alabama at Birmingham and other collaboratorsRecruitingPostpartum AnemiaZambia, Congo, The Democratic Republic of the, India, Bangladesh, Pakistan, Guatemala, Kenya
-
Indiana UniversityCompletedAnemia, Iron DeficiencyUnited States
-
Singapore General HospitalDuke-NUS Graduate Medical SchoolUnknownAnemia | Major Abdominal Surgery | Pre-operativeSingapore
-
University of OxfordColumbia University; ETH Zurich; Jomo Kenyatta University of Agriculture and... and other collaboratorsRecruitingPregnancy | Lactation | Iron Absorption | Iron Requirements | InfancyKenya
-
J. Uriach and CompanyUnknownColorectal Neoplasm | Iron Deficiency AnemiaSpain
-
Federal University of Juiz de ForaUnknownAnemia | Bowel Diseases, Inflammatory