Intravenous High Dose Iron in Blood Donors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Iron Deficiency

Intervention / Treatment
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* Drug: ferric carboxymaltose
* Drug: oral iron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Iron<br>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<br>* oral tablets of 100mg iron over 8 weeks, total dose 10g<br>* Other names: Ferretab;|
| Experimental: Intravenous high dose iron<br>high dose intravenous iron (ferric carboxymaltose, 1000mg) | Drug: ferric carboxymaltose<br>* 1 g intravenously per infusion<br>* Other names: ferinject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transferrin saturation (%) at visit 1 (V1) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events of different grades |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron depletion, donor safety, blood donation, transfusion medicine, iron deficiency, intravenous iron, fatigue, restless legs syndrome, anemia