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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoferrin Group | Active Comparator | 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. |
|
| Ferrous Sulfate Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline ferritin level | Diagnostic Test | At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum ferritin level | Change in serum ferritin level between enrollment and 4 weeks post-treatment. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea and/or vomiting | Incidence of treatment-related nausea and/or vomiting | 4 weeks |
| Dyspepsia | Incidence of treatment-related dyspepsia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghada Mohamed, MBBCh | G Darwish | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain SHams Maternity Hospital | Cairo | Abbaseya | 002 | Egypt |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| C020748 | ferrous sulfate |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
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| Lactoferrin | Drug | lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals). |
|
|
| Ferrous Sulfate | Drug | 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. |
|
|
| Follow up ferritin level | Diagnostic Test | Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status. |
|
| 4 weeks |
| Compliance to treatment | Number of missed doses of treatment from the assigned 30 doses | 4 weeks |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |