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

February 28, 2018 updated by: Ahmed Ragab, Ain Shams University

Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial

The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 11591
        • AinShams Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin level
Time Frame: 2 months
Measure hemoglobin level two months after treatment
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum ferritin
Time Frame: 2 months
Measure serum ferritin level
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2017

Primary Completion (ACTUAL)

December 10, 2017

Study Completion (ACTUAL)

January 15, 2018

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ainshams maternity hospital

Drug and device information, study documents

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

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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