Iron Deficiency Anemia
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTBaseline ferritin level
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
DRUGLactoferrin
lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
DRUGFerrous Sulfate
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.
DIAGNOSTIC_TESTFollow up ferritin level
Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum ferritin level | 4 weeks | Change in serum ferritin level between enrollment and 4 weeks post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea and/or vomiting | 4 weeks | Incidence of treatment-related nausea and/or vomiting |
| Dyspepsia | 4 weeks | Incidence of treatment-related dyspepsia |
| Compliance to treatment | 4 weeks | Number of missed doses of treatment from the assigned 30 doses |
Countries
Egypt
Outcome results
None listed