NCT03378791

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hatem AbuHashim · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Iron bisglycinate Oral Tablet
DRUG	Ferrous Fumarate Oral Tablet

Timeline

• Start date: 2015-12-31
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2017-12-20
• Last updated: 2017-12-20

Locations

1 site across 1 country: Egypt