Intravenous High Dose Iron in Blood Donors

NCT01787526 | Completed Phase 3

• 2 other identifiers: 1.02013-000327-14
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Iron Deficiency

Keywords

iron depletion; donor safety; blood donation; transfusion medicine; iron deficiency; intravenous iron; fatigue; restless legs syndrome; anemia

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (1)

• Number of patients with adverse events of different grades

  8 weeks

Other Outcomes (2)

• Other parameters of iron metabolism and red blood count

  8 weeks

• Subjective symptoms fatigue

  8 weeks

Study Arms (2)

Oral Iron

ACTIVE COMPARATOR

oral iron in a corresponding dose of 10g (assuming an absorption of 10%, 100 capsules a 100mg iron each) taken over 8-12 weeks

Drug: oral iron

Intravenous high dose iron

EXPERIMENTAL

high dose intravenous iron (ferric carboxymaltose, 1000mg)

Drug: ferric carboxymaltose

Interventions

ferric carboxymaltose DRUG

1 g intravenously per infusion

Also known as: ferinject

Intravenous high dose iron

oral iron DRUG

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

Also known as: Ferretab

Oral Iron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• hemochromatosis
• active infection
• pregnancy or lactation

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (12)

• 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.

  PMID: 21996651 BACKGROUND

• 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.

  PMID: 22212625 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.

  PMID: 17002622 BACKGROUND

• 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.

  PMID: 22023513 BACKGROUND

• 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.

  PMID: 21388389 BACKGROUND

• 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.

  PMID: 12147035 BACKGROUND

• 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.

  PMID: 13386295 BACKGROUND

• 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.

  PMID: 21942989 BACKGROUND

• 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.

  PMID: 20598107 BACKGROUND

• 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.

  PMID: 32380660 DERIVED

• 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.

  PMID: 30981629 DERIVED

• 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.

  PMID: 27793204 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Fatigue; Restless Legs Syndrome; Anemia

Interventions

ferric carboxymaltose; Iron

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Karin Amrein, MD

  Medical University Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: June 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2016-10

Locations

AU (1)