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A clinical open, randomised study of oral iron (Duroferon®) vs. intravenous iron (Ferinject®) for iron substitution in blood donors.

Conditions
Iron deficiency.
MedDRA version: 9.1Level: LLTClassification code 10022972Term: Iron deficiency anaemia
MedDRA version: 9.1Level: LLTClassification code 10022975Term: Iron deficiency anemia secondary to blood loss (chronic)
Registration Number
EUCTR2009-010623-64-SE
Lead Sponsor
Renapharma AB
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
210
Inclusion Criteria

•Males and females qualified as whole blood donors .
•Fulfilled at least 5 previous whole blood donations.
•Signed informed consent.

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Anaemia not attributable to iron deficiency, e.g. other type of microcytic anaemia.
•Iron overload.
•Contraindications for Ferinject® or Duroferon®.
•Contraindications for blood donations.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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