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

Iron Deficiency Anemia of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378791
• Other study ID #: MS/15.10.05
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2017
• Last updated: December 14, 2017
• Start date: December 31, 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: December 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia of Pregnancy

Intervention

Drug:
• Iron bisglycinate Oral Tablet

• Ferrous Fumarate Oral Tablet

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansourah	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Hatem AbuHashim

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level		At 4 weeks