Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women
Primary Purpose
Iron Deficiency Anemia of Pregnancy
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Iron bisglycinate Oral Tablet
Ferrous Fumarate Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women aged 20 to 40 years,
- 14-27 gestational weeks calculated from the first day of their last menstrual period and confirmed by ultrasound
- Singleton fetus
- hemoglobin level from 7-9.9 g/dL.
Exclusion Criteria:
- All women with high risk pregnancy e.g. hypertension, diabetes
- multiple pregnancy
- women with severe anemia (Hb >7 g/dl)
- anemia due to other causes than iron deficiency as chronic blood loss, hemolytic anemia or thalassemia.
- women with hepatic, renal or cardiovascular abnormality; women with peptic ulcer, esophagitis, gastritis or hiatus hernia
- family history of thalassemia, sickle cell anemia, or malabsorption syndrome
- hypersensitivity to iron preparations or current use of iron supplementation.
Sites / Locations
- Mansoura University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Iron bisglycinate (27mg of elemental iron)
Ferrous fumarate (115mg of elemental iron)
Outcomes
Primary Outcome Measures
Hemoglobin level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03378791
Brief Title
Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women
Official Title
Iron Bisglycinate Chelate or Ferrous Fumarate in Treatment of Iron Deficiency Anemia in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 31, 2015 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hatem AbuHashim
4. Oversight
5. Study Description
Brief Summary
Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11 g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the bioavailability of iron preparation, however it also increases the frequency of gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by many foods and / or chelating drugs in the gastrointestinal tract which interfere with its absorption leading to variability in the hemoglobin correction during the treatment.
Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron with two molecules of the amino acid glycine by a covalent bound in a process called chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves iron absorption, storage and increase hemoglobin level better than the conventionally used iron salts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Iron bisglycinate (27mg of elemental iron)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Ferrous fumarate (115mg of elemental iron)
Intervention Type
Drug
Intervention Name(s)
Iron bisglycinate Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Ferrous Fumarate Oral Tablet
Primary Outcome Measure Information:
Title
Hemoglobin level
Time Frame
At 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women aged 20 to 40 years,
14-27 gestational weeks calculated from the first day of their last menstrual period and confirmed by ultrasound
Singleton fetus
hemoglobin level from 7-9.9 g/dL.
Exclusion Criteria:
All women with high risk pregnancy e.g. hypertension, diabetes
multiple pregnancy
women with severe anemia (Hb >7 g/dl)
anemia due to other causes than iron deficiency as chronic blood loss, hemolytic anemia or thalassemia.
women with hepatic, renal or cardiovascular abnormality; women with peptic ulcer, esophagitis, gastritis or hiatus hernia
family history of thalassemia, sickle cell anemia, or malabsorption syndrome
hypersensitivity to iron preparations or current use of iron supplementation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD. MRCOG. PhD
Organizational Affiliation
Faculty of Medicine, Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Ismail, MBBCh
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansourah
State/Province
Dakahlia Governorate
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
24959663
Citation
Kamdi SP, Palkar PJ. Efficacy and safety of ferrous asparto glycinate in the management of iron deficiency anaemia in pregnant women. J Obstet Gynaecol. 2015 Jan;35(1):4-8. doi: 10.3109/01443615.2014.930098. Epub 2014 Jun 24.
Results Reference
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Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women
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