Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

• Status: Completed
• Trial end date: 2018-11-20
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Lactoferrin

Criteria

Inclusion Criteria:

• Pregnant women with single fetus.

• Second trimester (14-20weeks of gestation).

• Normal Hemoglobin level: more than10g\dl.

• Serum ferritin less than 15 mcg / L

Exclusion Criteria:

• Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.)

• Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases … etc.)

• Having hypersensitivity to iron preparations.

• Treatment with any other iron preparation in the last month.

• History of peptic ulcer, oesophagitis or hiatal hernia.

• Medical disorders with pregnancy.

• Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .

• Bleeding in early pregnancy.

• Refusal to participate in the study.

• Family history of thalassemia-sickle cell anemia or malabsorption syndrome.

• Recent blood transfusion.

• Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.