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

Iron Bisglycinate Chelate or Ferrous Fumarate in Treatment of Iron Deficiency Anemia in Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia of Pregnancy
• Intervention / Treatment: Drug: Iron bisglycinate Oral Tablet; Drug: Ferrous Fumarate Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Mansourah, Dakahlia Governorate, Egypt
      • Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Iron bisglycinate (27mg of elemental iron)	Drug: Iron bisglycinate Oral Tablet
Active Comparator: Group B; Ferrous fumarate (115mg of elemental iron)	Drug: Ferrous Fumarate Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin level	At 4 weeks

Collaborators and Investigators

• Sponsor: Hatem AbuHashim
• Investigators: Study Chair: Hatem Abu Hashim, MD. MRCOG. PhD, Faculty of Medicine, Mansoura University; Principal Investigator: Ahmed Ismail, MBBCh, Mansoura University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2015
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Physiological Effects of Drugs; Trace Elements; Micronutrients; Ferrous fumarate
• Other Study ID Numbers: MS/15.10.05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No