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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03481790

Enrollment

200

Registered

2018-03-29

Start date

2017-09-01

Completion date

2018-03-05

Last updated

2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia of Pregnancy

Keywords

iron deficiency anemia of pregnancy - lactoferrin

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.

Interventions

DRUGLactoferrin

(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.

DRUGferrous 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Hemoglobin (Hb) level.	4 weeks	to be measured before and after treatment.

Secondary

Measure	Time frame	Description
serum ferritin level.	4 weeks	to be measured before and after treatment.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026