Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia
NCT ID: NCT00929409
Last Updated: 2012-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2009-06-30
2010-07-31
Brief Summary
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The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.
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Detailed Description
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The amount of iron given to the intervention group is calculated according to the modified Ganzoni formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery.
The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power).
Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory.
Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peroral iron - ferrous sulfate tablets
Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily
Ferrous sulfate tablets
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Ferric carboxymaltose
Intravenous infusion of Ferric Carboxymaltose (Ferinject), the given dose is adapted according to the individual patient's requirement. No other form of iron supplementation is given.
Ferric carboxymaltose
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Interventions
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Ferric carboxymaltose
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Ferrous sulfate tablets
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemoglobin level equal or higher than 6.5 g/dl and equal or lower than 8.5 g/dl
* Able to read and understand the Norwegian language
* Signed informed consent
Exclusion Criteria
* Contraindications for any of the study drugs
* Treatment with drugs, dietary supplements or natural remedies containing iron
* Clinically significant condition which in the opinion of the investigator should disqualify the patient from the study
* Assessed as requiring blood transfusion(s)
18 Years
45 Years
FEMALE
No
Sponsors
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St. Olavs Hospital
OTHER
Sykehuset Innlandet HF
OTHER
Sykehuset Buskerud HF
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Bjorn Backe, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Locations
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Department of Obstetrics, Vestre Viken Hospital Trust
Drammen, , Norway
Sykehuset Innlandet HF
Lillehammer, , Norway
St Olavs Hospital
Trondheim, , Norway
Countries
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Other Identifiers
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21830
Identifier Type: OTHER
Identifier Source: secondary_id
09/03045-4
Identifier Type: OTHER
Identifier Source: secondary_id
2008-008526-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
4.2009.373
Identifier Type: -
Identifier Source: org_study_id
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