NCT03759353

Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance. Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects. This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Baseline ferritin level	At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
DRUG	Lactoferrin	lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
DRUG	Ferrous Sulfate	200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.
DIAGNOSTIC_TEST	Follow up ferritin level	Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.

Timeline

• Start date: 2018-01-15
• Primary completion: 2018-10-30
• Completion: 2018-11-20
• First posted: 2018-11-30
• Last updated: 2018-11-30

Locations

1 site across 1 country: Egypt