Intravenous High Dose Iron in Blood Donors (IronWoMan)

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency

Treatments: Drug: ferric carboxymaltose; Drug: oral iron

Study type: Interventional

Funder types: Other

Identifiers

NCT01787526

2013-000327-14 (EudraCT Number)

1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Oral Iron

Active Comparator group

Description:

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

Treatment:

Drug: oral iron

Intravenous high dose iron

Experimental group

Description:

high dose intravenous iron (ferric carboxymaltose, 1000mg)

Treatment:

Drug: ferric carboxymaltose