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

Iron Deficiency Anemia of Pregnancy Clinical Trial

Official title:

The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481790
• Other study ID #: AinShams Maternity Hospital
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2018
• Last updated: March 22, 2018
• Start date: September 1, 2017
• Est. completion date: March 5, 2018

Study information

• Verified date: March 2018
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia of Pregnancy

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin (Hb) level.	to be measured before and after treatment.	4 weeks
Secondary	serum ferritin level.	to be measured before and after treatment.	4 weeks