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

NCT ID: NCT03378791

Last Updated: 2017-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-10-31

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.

Conditions

Iron Deficiency Anemia of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Iron bisglycinate (27mg of elemental iron)

Group Type: EXPERIMENTAL

Iron bisglycinate Oral Tablet

Intervention Type: DRUG

Group B

Ferrous fumarate (115mg of elemental iron)

Group Type: ACTIVE_COMPARATOR

Ferrous Fumarate Oral Tablet

Intervention Type: DRUG

Interventions

Iron bisglycinate Oral Tablet

Intervention Type: DRUG

Ferrous Fumarate Oral Tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hatem AbuHashim

OTHER

Sponsor Role: lead

Responsible Party

Hatem AbuHashim

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hatem Abu Hashim, MD. MRCOG. PhD

Role: STUDY_CHAIR

Faculty of Medicine, Mansoura University

Ahmed Ismail, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 24959663 (View on PubMed)

Other Identifiers

MS/15.10.05

Identifier Type: -

Identifier Source: org_study_id