Comparison Study of Intravenous (IV) Versus Oral Iron (Fe) for Iron Deficiency Anemia Treatment in Late Pregnancy - Full Text View

Sponsors and Collaborators:	Mahidol University Vifor Inc.
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00746551

Purpose

The purpose of this study is to compare the efficacy of treatment between intravenous iron sucrose and oral iron fumarate in pregnant women in the third trimester.

Condition	Intervention	Phase
Anemia Pregnancy Complications	Drug: Ferli-6® (Continental Pharm co., ltd.) Drug: Venofer® (Vifor AG, St. Gallen, Switzerland)	Phase IV

MedlinePlus related topics: Anemia

Drug Information available for: Sucrose Ferric oxide, saccharated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Intravenous Versus Oral Iron for Treatment of Iron Deficiency Anemic Pregnant Women in the 3rd Trimester: A Randomized Trial

Further study details as provided by Mahidol University:

Primary Outcome Measures:

serum ferritin level [ Time Frame: 3 weeks after intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

hemoglobin level [ Time Frame: 3 weeks after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	September 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator oral iron	Drug: Ferli-6® (Continental Pharm co., ltd.) iron fumarate oral tablet, 200 mg of elemental iron per day,until delivery
2: Experimental Intravenous iron sucrose	Drug: Venofer® (Vifor AG, St. Gallen, Switzerland) Intravenous iron sucrose Ampule (100 mg/5ml), total dose needed = [body weight x (the required Hb - the woman's Hb) x 0.24] + 500 mg, the maximum dose per administration is 200 mg which will be given weekly until the required dose is reached.

Detailed Description:

Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intravenous iron for IDA treatment has been carried out in the third trimester of pregnancy. Therefore, the authors aim to compare the efficacy of IDA treatment between intravenous iron sucrose and oral iron fumarate during late pregnancy. In this study,the intravenous iron administration module has been modified to be given weekly instead of every other day for the sake of patient's convenience in the hope that parenteral iron may become another alternative for treatment of pregnant women with iron deficiency anemia who have difficulties or failures with oral iron.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-45 years old
Singleton pregnancy at 32 weeks gestation
Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of < 11 g/dL or hematocrit of < 33%
Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
Having no history of allergy to iron containing medication
Having no history or other allergic conditions or asthma
Having no thalassemia disease, for examples: B thalassemia major, Hb E/ B thalassemia, homozygous HbE, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study.
Having no history of bleeding tendency
Having no history of blood transfusion within the prior 120 days
Having no history of delivery before 36 weeks gestation
Giving consent and having signed the consent form for this study

Exclusion Criteria:

Stool exam revealed parasitic infestation
C-reactive protein > 3 mg/L
Serum ferritin > 15 mcg/L

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746551

Contacts

Contact: Pornpimol Ruangvutilert, MD, Ph.D.	+66 -(0)8-1917-0809	siprv@mahidol.ac.th
Contact: Pharuhas Chanprapaph, MD, MsC.	+66 -(0)8-1992-0053	pharuhasc@gmail.com, sipcj@mahidol.ac.th

Locations

Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Vifor Inc.

Investigators

Principal Investigator:

Pornpimol Ruangvutilert, MD, PhD.

Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University

More Information

Responsible Party:	Faculty of Medicine Siriraj Hospital, Mahidol University ( Pornpimol Ruangvutilert/Associate Professor )
Study ID Numbers:	296/2551(EC3)
Study First Received:	September 2, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00746551
Health Authority:	United States: Institutional Review Board

Keywords provided by Mahidol University:

iron deficiency anemia
pregnancy
third trimester
intravenous iron
efficacy

a randomized trial
Female
Ferric Compounds/therapeutic use*
Infusions, Intravenous
Hematologic/therapy*

Study placed in the following topic categories:

Ferric oxide, saccharated
Metabolic Diseases
Pregnancy Complications
Ferric Compounds
Hematologic Diseases

Anemia
Iron Metabolism Disorders
Metabolic disorder
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Anemia, Hypochromic

Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009