The Effect of Iron Deficiency Anemia During Pregnancy

Iron Deficiency Anemia Clinical Trial

Official title:

Ferrous Bis-glycinate Versus Ferrous Glycine Sulfate for the Treatment of Iron Deficiency Anemia During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590224
• Other study ID #: IDA
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2015
• Last updated: March 17, 2018
• Start date: January 1, 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Ferrous bis-glycinate

• Ferrous glycine sulphate

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of increase of Hemoglobin level	difference in hemoglobin concentrations before and after treatment	8 weeks