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

Study Overview
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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.

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.

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

Conditions
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Iron Deficiency Anemia of Pregnancy

Intervention / Treatment
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* Drug: Lactoferrin
* Drug: ferrous sulphate + folic acid (vitamin B9)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoferrin<br>100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day. | Drug: Lactoferrin<br>* (Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.<br>* Other names: MamyVital;|
| Experimental: ferrous sulphate + folic acid (vitamin B9)<br>150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day. | Drug: ferrous sulphate + folic acid (vitamin B9)<br>* (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.<br>* Other names: Ferrofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) level. | to be measured before and after treatment. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum ferritin level. | to be measured before and after treatment. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia of pregnancy - lactoferrin