Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Study Overview
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Brief Summary
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The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance. Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects. This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.

Official Title
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A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Diagnostic Test: Baseline ferritin level
* Drug: Lactoferrin
* Drug: Ferrous Sulfate
* Diagnostic Test: Follow up ferritin level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with single fetus. Second trimester (14-20weeks of gestation). Normal Hemoglobin level: more than10g\dl. Serum ferritin less than 15 mcg / L Exclusion Criteria: Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.) Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases … etc.) Having hypersensitivity to iron preparations. Treatment with any other iron preparation in the last month. History of peptic ulcer, oesophagitis or hiatal hernia. Medical disorders with pregnancy. Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) . Bleeding in early pregnancy. Refusal to participate in the study. Family history of thalassemia-sickle cell anemia or malabsorption syndrome. Recent blood transfusion. Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 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
Interventional Model Description: 98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactoferrin Group<br>Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment. | Diagnostic Test: Baseline ferritin level<br>* At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.<br>Drug: Lactoferrin<br>* lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).<br>* Other names: Pravotin;Diagnostic Test: Follow up ferritin level<br>* Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.<br>|
| Active Comparator: Ferrous Sulfate Group<br>Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment. | Diagnostic Test: Baseline ferritin level<br>* At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.<br>Drug: Ferrous Sulfate<br>* 200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.<br>* Other names: Feosol;Diagnostic Test: Follow up ferritin level<br>* Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum ferritin level | Change in serum ferritin level between enrollment and 4 weeks post-treatment. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and/or vomiting | Incidence of treatment-related nausea and/or vomiting | 4 weeks | 
| Dyspepsia | Incidence of treatment-related dyspepsia | 4 weeks | 
| Compliance to treatment | Number of missed doses of treatment from the assigned 30 doses | 4 weeks |