- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759353
Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Abbaseya
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Cairo, Abbaseya, Egypt, 002
- Ain Shams Maternity Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lactoferrin Group
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.
|
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
Other Names:
Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
|
Active Comparator: Ferrous Sulfate Group
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.
|
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum ferritin level
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
Incidence of treatment-related nausea and/or vomiting
|
4 weeks
|
Dyspepsia
Time Frame: 4 weeks
|
Incidence of treatment-related dyspepsia
|
4 weeks
|
Compliance to treatment
Time Frame: 4 weeks
|
Number of missed doses of treatment from the assigned 30 doses
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ghada Mohamed, MBBCh, G Darwish
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LactvsFerr
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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