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NCT Number: NCT01787526

Intravenous High Dose Iron in Blood Donors

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.

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Key information

Conditions

Iron Deficiency Anemia Dyssomnias Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Parasomnias Pathological Conditions, Signs and Symptoms Restless Legs Syndrome Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferric carboxymaltose

Drug

1 g intravenously per infusion

Other names: ferinject

oral iron

Drug

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

Other names: Ferretab

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  1. Number of patients with adverse events of different grades

    Time frame: 8 weeks

Other outcomes

  1. Other parameters of iron metabolism and red blood count

    Time frame: 8 weeks

  2. Subjective symptoms fatigue

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: IronWoMan

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2013
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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