Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Iron Sucrose Injection
Ferrous Bisglycinate
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age >38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study
Exclusion Criteria:
- Severe anemia < 7 gm/dl.
- Women received iron therapy during pregnancy.
- Intolerance to iron preparations
- Anemia due to other causes
- Peripartum blood transfusion.
Sites / Locations
- Assiut Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravenous iron
Oral ferrous bis-glycinate
Arm Description
Women will receive iron sucrose (sacrofer ampules 100 mg/5ml) A patient's total body iron deficit will be calculated using the Ganzoni formula (total iron dose = [body weight (kilogram)× (15-actual Hemoglobin)] × 2.4 + 500 mg) then the total dose will be divided on 3 settings
Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets
Outcomes
Primary Outcome Measures
the percentage of patients achieving Hb rise 3 gm or more
Secondary Outcome Measures
Mean rise of Hb from baseline to 6 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03009578
Brief Title
Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia
Official Title
Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
June 5, 2018 (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
Yes
5. Study Description
Brief Summary
Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations.
Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia
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
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous iron
Arm Type
Experimental
Arm Description
Women will receive iron sucrose (sacrofer ampules 100 mg/5ml) A patient's total body iron deficit will be calculated using the Ganzoni formula (total iron dose = [body weight (kilogram)× (15-actual Hemoglobin)] × 2.4 + 500 mg) then the total dose will be divided on 3 settings
Arm Title
Oral ferrous bis-glycinate
Arm Type
Active Comparator
Arm Description
Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose Injection
Intervention Description
iron Intramuscular injections
Intervention Type
Drug
Intervention Name(s)
Ferrous Bisglycinate
Intervention Description
oral iron tablets
Primary Outcome Measure Information:
Title
the percentage of patients achieving Hb rise 3 gm or more
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Mean rise of Hb from baseline to 6 weeks.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age >38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study
Exclusion Criteria:
Severe anemia < 7 gm/dl.
Women received iron therapy during pregnancy.
Intolerance to iron preparations
Anemia due to other causes
Peripartum blood transfusion.
Facility Information:
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia
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