Back to resultsLactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Baseline ferritin level
Lactoferrin
Ferrous Sulfate
Follow up ferritin level
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia
Eligibility Criteria
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.
Sites / Locations
- Ain SHams Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lactoferrin Group
Ferrous Sulfate Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in serum ferritin level
Change in serum ferritin level between enrollment and 4 weeks post-treatment.
Secondary Outcome Measures
Nausea and/or vomiting
Incidence of treatment-related nausea and/or vomiting
Dyspepsia
Incidence of treatment-related dyspepsia
Compliance to treatment
Number of missed doses of treatment from the assigned 30 doses
Full Information
NCT ID
NCT03759353
First Posted
November 28, 2018
Last Updated
November 28, 2018
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03759353
Brief Title
Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
Official Title
A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactoferrin Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ferrous Sulfate Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Baseline ferritin level
Intervention Description
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
Intervention Type
Drug
Intervention Name(s)
Lactoferrin
Other Intervention Name(s)
Pravotin
Intervention Description
lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Other Intervention Name(s)
Feosol
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Follow up ferritin level
Intervention Description
Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
Primary Outcome Measure Information:
Title
Change in serum ferritin level
Description
Change in serum ferritin level between enrollment and 4 weeks post-treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Nausea and/or vomiting
Description
Incidence of treatment-related nausea and/or vomiting
Time Frame
4 weeks
Title
Dyspepsia
Description
Incidence of treatment-related dyspepsia
Time Frame
4 weeks
Title
Compliance to treatment
Description
Number of missed doses of treatment from the assigned 30 doses
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada Mohamed, MBBCh
Organizational Affiliation
G Darwish
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain SHams Maternity Hospital
City
Cairo
State/Province
Abbaseya
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
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