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

Depression, Postpartum Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00929409
• Other study ID #: 4.2009.373
• Secondary ID: 2183009/03045-42
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 26, 2009
• Last updated: February 15, 2012
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: February 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway: Norwegian Medicines AgencyNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Depression, Postpartum
• Puerperal Disorders

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Norway	Department of Obstetrics, Vestre Viken Hospital Trust	Drammen
Norway	Sykehuset Innlandet HF	Lillehammer
Norway	St Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital, Sykehuset Buskerud HF, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin concentration		6 weeks	No
Secondary	Ferritin		6 weeks	No
Secondary	Fatigue	Fatigue scale	6 weeks	No
Secondary	Quality of life	SF-36	6 weeks	No
Secondary	Post partum depression	Edinburgh Post Partum Depression Scale	6 weeks	No