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

Hatem AbuHashim

Status and phase

Completed

Phase 3

Conditions

Iron Deficiency Anemia of Pregnancy

Treatments

Drug: Iron bisglycinate Oral Tablet

Drug: Ferrous Fumarate Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT03378791

MS/15.10.05

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.