Intravenous High Dose Iron in Blood Donors (IronWoMan)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01787526
First received: February 6, 2013
Last updated: June 1, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Iron Deficiency
Drug: ferric carboxymaltose
Drug: oral iron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Intravenous Iron in Blood Donors With Iron Deficiency: a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • transferrin saturation (%) at visit 1 (V1) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events of different grades [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Other parameters of iron metabolism and red blood count [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Subjective symptoms fatigue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: oral iron
Experimental: Intravenous high dose iron
high dose intravenous iron (ferric carboxymaltose, 1000mg)
Drug: ferric carboxymaltose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787526

Contacts
Contact: Karin Amrein, MD, MSc 43/316/3850 ext 80798 karin.amrein@medunigraz.at
Contact: Camilla Drexler, MD 43/316/3850 ext 83066 camilla.drexler@klinikum-graz.at

Locations
Austria
Medical University of Graz Not yet recruiting
Graz, Austria, 8036
Principal Investigator: Karin Amrein, MD, MSc         
Sub-Investigator: Camilla Drexler, MD         
Sub-Investigator: Nazanin Sareban, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Karin Amrein, MD Medical University Graz, Austria
  More Information

Publications:

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01787526     History of Changes
Other Study ID Numbers: 1.0, 2013-000327-14
Study First Received: February 6, 2013
Last Updated: June 1, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
iron depletion
donor safety
blood donation
transfusion medicine
iron deficiency
intravenous iron
fatigue
restless legs syndrome
anemia

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014