Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women

Phase 3

Completed

• Conditions: Iron Deficiency Anemia of Pregnancy
• Interventions: Drug: Ferrous Fumarate Oral Tablet; Drug: Iron bisglycinate Oral Tablet

• Registration Number: NCT03378791
• Lead Sponsor: Hatem AbuHashim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-31
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2017-12
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Study First Posted: 2017-12-20
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Ferrous Fumarate Oral Tablet	Ferrous fumarate (115mg of elemental iron)
Group A	Iron bisglycinate Oral Tablet	Iron bisglycinate (27mg of elemental iron)

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	At 4 weeks

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansourah, Dakahlia Governorate, Egypt