NCT02590224

The Effect of Iron Deficiency Anemia During Pregnancy

Ferrous Bis-glycinate Versus Ferrous Glycine Sulfate for the Treatment of Iron Deficiency Anemia During Pregnancy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations. Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication. Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferrous bis-glycinate
DRUG	Ferrous glycine sulphate

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2015-10-28
• Last updated: 2018-03-20

Locations

1 site across 1 country: Egypt