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Trial record 48 of 385 for:    FERRIC CATION

Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929409
Recruitment Status : Terminated (Stopped prematurely because too few patients were recruited.)
First Posted : June 29, 2009
Last Update Posted : February 17, 2012
St. Olavs Hospital
Sykehuset Innlandet HF
Sykehuset Buskerud HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group).

The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Puerperal Disorders Depression, Postpartum Drug: Ferric carboxymaltose Drug: Ferrous sulfate tablets Phase 2 Phase 3

Detailed Description:

The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia
Study Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Active Comparator: Peroral iron - ferrous sulfate tablets
Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily
Drug: Ferrous sulfate tablets
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Other Name: Duroferon

Active Comparator: 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.
Drug: Ferric carboxymaltose
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Other Name: Ferinject

Primary Outcome Measures :
  1. Haemoglobin concentration [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Ferritin [ Time Frame: 6 weeks ]
  2. Fatigue [ Time Frame: 6 weeks ]
    Fatigue scale

  3. Quality of life [ Time Frame: 6 weeks ]

  4. Post partum depression [ Time Frame: 6 weeks ]
    Edinburgh Post Partum Depression Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Woman within 48 h post partum
  • 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:

  • Anemia not attributable to iron deficiency
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00929409

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Department of Obstetrics, Vestre Viken Hospital Trust
Drammen, Norway, 3004
Sykehuset Innlandet HF
Lillehammer, Norway, N 2609
St Olavs Hospital
Trondheim, Norway, N 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Sykehuset Innlandet HF
Sykehuset Buskerud HF
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Principal Investigator: Bjorn Backe, MD PhD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology Identifier: NCT00929409     History of Changes
Other Study ID Numbers: 4.2009.373
21830 ( Other Identifier: NSD, Norway )
09/03045-4 ( Other Identifier: SLV, Norway )
2008-008526-79 ( EudraCT Number )
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012
Keywords provided by Norwegian University of Science and Technology:
Postpartum anemia, iron-deficiency
Additional relevant MeSH terms:
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Ferric Compounds
Depression, Postpartum
Puerperal Disorders
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders
Trace Elements
Growth Substances
Physiological Effects of Drugs