Intravenous application of iron in high dosage in blood donors with iron deficiency: a randomized, controlled trial

• Conditions: One of the most common risks of blood donation is iatrogenic iron deficiency, as each whole blood donation causes a loss of 200 to 250 mg of iron. Within the scope of this trial blood donors are screened for iron deficiency and as a consequence of low iron stores invited to participate in this trial. Parameter for low iron stores is Ferritin and a value below 30 ng/ml is required for inclusion in the study.; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-000327-14-AT
• Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Stoffwechsel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-09
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age >= 18 years and <= 65 years
- Ferritin <= 30 ng/ml
- Fulfilment of the strict criteria for blood donation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Hemochromatosis
- Active infection
- Pregnancy or lactation
- History of anaphylaxis to intravenous iron or other substances
- Signs or symptoms suggestive for acute or chronic gastrointestinal bleeding and/or hypermenorrhoea

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified