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

This study has been terminated.
(Stopped prematurely because too few patients were recruited.)
Sponsor:
Collaborators:
St. Olavs Hospital
Sykehuset Innlandet HF
Sykehuset Buskerud HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00929409
First received: June 26, 2009
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Haemoglobin concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ferritin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Fatigue scale

  • Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    SF-36

  • Post partum depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Edinburgh Post Partum Depression Scale


Enrollment: 30
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929409

Locations
Norway
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
Investigators
Principal Investigator: Bjorn Backe, MD PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00929409     History of Changes
Other Study ID Numbers: 4.2009.373, 21830, 09/03045-4, 2008-008526-79
Study First Received: June 26, 2009
Last Updated: February 15, 2012
Health Authority: Norway: Norwegian Social Science Data Services
Norway: Norwegian Medicines Agency
Norway: Directorate of Health

Keywords provided by Norwegian University of Science and Technology:
Postpartum anemia, iron-deficiency

Additional relevant MeSH terms:
Anemia
Depression
Depressive Disorder
Puerperal Disorders
Anemia, Iron-Deficiency
Depression, Postpartum
Hematologic Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pregnancy Complications
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014