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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-03-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiency Anemia of Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lactoferrin

100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.

Group Type EXPERIMENTAL

Lactoferrin

Intervention Type DRUG

(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)

150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.

Group Type EXPERIMENTAL

ferrous sulphate + folic acid (vitamin B9)

Intervention Type DRUG

(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.

Interventions

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Lactoferrin

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Pravotin MamyVital Ferrofol

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No