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Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03456258
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
4.3
Actual Duration (Months)
23.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Complete blood count
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial
Actual Study Start Date :
Sep 5, 2017
Actual Primary Completion Date :
Dec 10, 2017
Actual Study Completion Date :
Jan 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lactoferrin

To measure hemoglobin difference and serum ferritin

Diagnostic Test: Complete blood count
To measure hemoglobin difference and serum ferritin levels .
Other Names:
  • Serum ferritin

    		•
    Experimental: Ferrous sulphate

    To measure hemoglobin difference and serum ferritin

    Diagnostic Test: Complete blood count
    To measure hemoglobin difference and serum ferritin levels .
    Other Names:
  • Serum ferritin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. hemoglobin level [2 months]

      Measure hemoglobin level two months after treatment

    Secondary Outcome Measures

    1. Serum ferritin [2 months]

      Measure serum ferritin level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ainshams maternity hospital Cairo Abbasia Egypt 11591

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ahmed M Ragab, MBBCH, Ainshams university maternity hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Ragab, Principal investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03456258
    Other Study ID Numbers:
    • Ainshams maternity hospital
    First Posted:
    Mar 7, 2018
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Feb 1, 2018
    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
    Additional relevant MeSH terms:
    Anemia
    Anemia, Iron-Deficiency
    Deficiency Diseases

    Study Results

    No Results Posted as of Mar 7, 2018