Back to resultsIron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Iron dextran
Ferrous Fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Hemoglobin < 10 g/dL
- Gestational age between 14-28 weeks.
- Willingness to participate and signing the informed consent form.
Exclusion Criteria:
- Iron overload or disturbances in utilization of iron
- Decompensated liver cirrhosis and active hepatitis
- Active acute or chronic infections
- History of multiple allergies
- Known hypersensitivity to parenteral iron or any recipients in the investigation drug products
- Erythropoietin treatment within 8 weeks prior to the screening visit
- Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
- Planned elective surgery during the study.
Sites / Locations
- Assiut Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intravenous iron
oral iron
Arm Description
patients will receive intravenous iron as total dose infusion
patients will receive oral iron
Outcomes
Primary Outcome Measures
The change in Hemoglobin concentration from baseline to 8 weeks therapy
measure hemoglobin level before and after treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03212781
Brief Title
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women
Official Title
Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Iron deficiency is the most prevalent nutritional deficiency and the most common cause of anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells that are abnormally small (microcytic) and contain a decreased amount of hemoglobin (hypochromic).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intravenous iron
Arm Type
Experimental
Arm Description
patients will receive intravenous iron as total dose infusion
Arm Title
oral iron
Arm Type
Active Comparator
Arm Description
patients will receive oral iron
Intervention Type
Drug
Intervention Name(s)
Iron dextran
Intervention Description
total dose infusion
Intervention Type
Drug
Intervention Name(s)
Ferrous Fumarate
Intervention Description
oral tablets
Primary Outcome Measure Information:
Title
The change in Hemoglobin concentration from baseline to 8 weeks therapy
Description
measure hemoglobin level before and after treatment
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemoglobin < 10 g/dL
Gestational age between 14-28 weeks.
Willingness to participate and signing the informed consent form.
Exclusion Criteria:
Iron overload or disturbances in utilization of iron
Decompensated liver cirrhosis and active hepatitis
Active acute or chronic infections
History of multiple allergies
Known hypersensitivity to parenteral iron or any recipients in the investigation drug products
Erythropoietin treatment within 8 weeks prior to the screening visit
Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
Planned elective surgery during the study.
Facility Information:
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women
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