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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03378791
Other study ID # MS/15.10.05
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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