Back to resultsLactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy (Lactoferrin)
Primary Purpose
Iron Deficiency Anemia of Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Complete blood count
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy
Eligibility Criteria
Inclusion Criteria:
- pregnant women from 20 to 40 years
- iron deficiency anemia (mild and moderate)
- gestational age 13 to 26 weeks
- singleton viable pregnancy.
Exclusion Criteria:
- history of anemia due to chronic blood loss
- hemolytic anemia
- severe anemia
- history of peptic ulcer
Sites / Locations
- Ainshams maternity hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lactoferrin
Ferrous sulphate
Arm Description
To measure hemoglobin difference and serum ferritin
To measure hemoglobin difference and serum ferritin
Outcomes
Primary Outcome Measures
hemoglobin level
Measure hemoglobin level two months after treatment
Secondary Outcome Measures
Serum ferritin
Measure serum ferritin level
Full Information
NCT ID
NCT03456258
First Posted
February 23, 2018
Last Updated
February 28, 2018
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03456258
Brief Title
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy
Acronym
Lactoferrin
Official Title
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
December 10, 2017 (Actual)
Study Completion Date
January 15, 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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.
Detailed Description
The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups .
Group one lactoferrin group Group two ferrous sulphate group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactoferrin
Arm Type
Experimental
Arm Description
To measure hemoglobin difference and serum ferritin
Arm Title
Ferrous sulphate
Arm Type
Experimental
Arm Description
To measure hemoglobin difference and serum ferritin
Intervention Type
Diagnostic Test
Intervention Name(s)
Complete blood count
Other Intervention Name(s)
Serum ferritin
Intervention Description
To measure hemoglobin difference and serum ferritin levels .
Primary Outcome Measure Information:
Title
hemoglobin level
Description
Measure hemoglobin level two months after treatment
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Serum ferritin
Description
Measure serum ferritin level
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant women from 20 to 40 years
iron deficiency anemia (mild and moderate)
gestational age 13 to 26 weeks
singleton viable pregnancy.
Exclusion Criteria:
history of anemia due to chronic blood loss
hemolytic anemia
severe anemia
history of peptic ulcer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Ragab, MBBCH
Organizational Affiliation
Ainshams university maternity hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ainshams maternity hospital
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy
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