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

Ain Shams Maternity Hospital

Status and phase

Completed

Phase 2

Conditions

Iron Deficiency Anemia of Pregnancy

Treatments

Drug: ferrous sulphate + folic acid (vitamin B9)

Drug: Lactoferrin

Study type

Interventional

Funder types

Other

Identifiers

NCT03481790

AinShams Maternity Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

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)