Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

November 28, 2018 updated by: Ghada Mohamed Ahmed, Ain Shams University

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

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

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

    • Abbaseya
      • Cairo, Abbaseya, Egypt, 002
        • Ain Shams 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

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

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 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:
  • Pravotin
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:
  • Feosol

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

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

Investigators

  • Principal Investigator: Ghada Mohamed, MBBCh, G Darwish

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)

January 15, 2018

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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