CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 176 enrolled
Drug / intervention
ferric carboxymaltose +1 moredrug
Likely dose
ferric carboxymaltose 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01787526
NCT01787526Phase 3Completed

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

Medical University of Graz·interventional·Posted Feb 8, 2013·Updated Oct 6, 2016

In Brief

A Phase 3 clinical trial evaluating ferric carboxymaltose and oral iron for Iron Deficiency. Completed, enrolled 176 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency
CountriesAustria
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartJun 1, 2014
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.4 years ago

Interventions

ferric carboxymaltosedrug

1 g intravenously per infusion

oral irondrug

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