The Effect of Iron Deficiency Anemia During Pregnancy

Phase 4

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Ferrous bis-glycinate; Drug: Ferrous glycine sulphate

• Registration Number: NCT02590224
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2016-01-01
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-17
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous bis-glycinate group	Ferrous bis-glycinate	The patients will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets (Pharaferro 27 tablets) once daily for eight consecutive weeks.
Ferrous glycine sulphate group	Ferrous glycine sulphate	The patients will receive 567.6 mg of ferrous glycine sulphate capsules (Ferrosanol duodenale capsules, Schwarz) once daily for eight consecutive weeks.

Primary Outcome Measures

Name	Time	Method
the rate of increase of Hemoglobin level	8 weeks	difference in hemoglobin concentrations before and after treatment

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt