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

NCT03378791 | Completed Phase 3

• 1 other identifier: MS/15.10.05
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  At 4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Iron bisglycinate (27mg of elemental iron)

Drug: Iron bisglycinate Oral Tablet

Group B

ACTIVE COMPARATOR

Ferrous fumarate (115mg of elemental iron)

Drug: Ferrous Fumarate Oral Tablet

Interventions

Iron bisglycinate Oral Tablet DRUG

Group A

Ferrous Fumarate Oral Tablet DRUG

Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 20 to 40 years,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatem AbuHashim: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (1)

• 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.

  PMID: 24959663 BACKGROUND

MeSH Terms

Interventions

ferrous fumarate

Study Officials

• Hatem Abu Hashim, MD. MRCOG. PhD

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

• Ahmed Ismail, MBBCh

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: December 31, 2015
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

EG (1)