NCT03481790

Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy

The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy. Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.

Detailed description

Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy. Ferrous sulphate is the most commonly used treatment for iron deficiency anemia. Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.

Conditions

• Iron Deficiency Anemia of Pregnancy

Interventions

Type	Name	Description
DRUG	Lactoferrin	(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.
DRUG	ferrous sulphate + folic acid (vitamin B9)	(Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-03-05
• Completion: 2018-03-05
• First posted: 2018-03-29
• Last updated: 2018-03-29

Locations

1 site across 1 country: Egypt