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The Effect of Iron Deficiency Anemia During Pregnancy

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ferrous bis-glycinate
Ferrous glycine sulphate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Singleton pregnancy.
  2. Gestational age 14-18 weeks.
  3. Mild to moderate anemia
  4. No associated medical or obstetric complications.
  5. Women not already receiving iron therapy.
  6. Women accepted to participate in the study.

Exclusion Criteria:

  1. Multiple pregnancy
  2. Severe anemia
  3. Iron hypersensitivity.
  4. Liver diseases.
  5. Women refuse to participate in the study.

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ferrous bis-glycinate group

Ferrous glycine sulphate group

Arm Description

The patients will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets (Pharaferro 27 tablets) once daily for eight consecutive weeks.

The patients will receive 567.6 mg of ferrous glycine sulphate capsules (Ferrosanol duodenale capsules, Schwarz) once daily for eight consecutive weeks.

Outcomes

Primary Outcome Measures

the rate of increase of Hemoglobin level
difference in hemoglobin concentrations before and after treatment

Secondary Outcome Measures

Full Information

First Posted
October 27, 2015
Last Updated
March 17, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02590224
Brief Title
The Effect of Iron Deficiency Anemia During Pregnancy
Official Title
Ferrous Bis-glycinate Versus Ferrous Glycine Sulfate for the Treatment of Iron Deficiency Anemia During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations. Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication. Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferrous bis-glycinate group
Arm Type
Active Comparator
Arm Description
The patients will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets (Pharaferro 27 tablets) once daily for eight consecutive weeks.
Arm Title
Ferrous glycine sulphate group
Arm Type
Active Comparator
Arm Description
The patients will receive 567.6 mg of ferrous glycine sulphate capsules (Ferrosanol duodenale capsules, Schwarz) once daily for eight consecutive weeks.
Intervention Type
Drug
Intervention Name(s)
Ferrous bis-glycinate
Intervention Type
Drug
Intervention Name(s)
Ferrous glycine sulphate
Primary Outcome Measure Information:
Title
the rate of increase of Hemoglobin level
Description
difference in hemoglobin concentrations before and after treatment
Time Frame
8 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: Singleton pregnancy. Gestational age 14-18 weeks. Mild to moderate anemia No associated medical or obstetric complications. Women not already receiving iron therapy. Women accepted to participate in the study. Exclusion Criteria: Multiple pregnancy Severe anemia Iron hypersensitivity. Liver diseases. Women refuse to participate in the study.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

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The Effect of Iron Deficiency Anemia During Pregnancy

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