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

Phase 2

Completed

• Conditions: Iron Deficiency Anemia of Pregnancy
• Interventions: Drug: Lactoferrin; Drug: ferrous sulphate + folic acid (vitamin B9)

• Registration Number: NCT03481790
• Lead Sponsor: Ain Shams Maternity Hospital

Brief 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.

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2018-03
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-22
• Last Update Submitted: 2018-03-22
• Study First Posted: 2018-03-29
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Pregnant women with single fetus
• Hb count < 11g/dL
• ferritin level < 12 ng/dL
• Gestational age (14 - 30 weeks)

Exclusion Criteria

• Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
• Associated bleeding disorder
• Anaemia requiring blood tranfusion (Hb < 7g/dL)
• Hypersensitivity to iron preparations
• Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoferrin	Lactoferrin	100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.
ferrous sulphate + folic acid (vitamin B9)	ferrous sulphate + folic acid (vitamin B9)	150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.

Primary Outcome Measures

Name	Time	Method
Hemoglobin (Hb) level.	4 weeks	to be measured before and after treatment.

Secondary Outcome Measures

Name	Time	Method
serum ferritin level.	4 weeks	to be measured before and after treatment.

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt