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Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03759353
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
10.2
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Baseline ferritin level
  • Drug: Lactoferrin
  • Drug: Ferrous Sulfate
  • Diagnostic Test: Follow up ferritin level
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
Actual Study Start Date :
Jan 15, 2018
Actual Primary Completion Date :
Oct 30, 2018
Actual Study Completion Date :
Nov 20, 2018

Arms and Interventions

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.

Diagnostic Test: Baseline ferritin level
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.

Drug: Lactoferrin
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

    • Diagnostic Test: Follow up ferritin level
    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.

    Diagnostic Test: Baseline ferritin level
    At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.

    Drug: Ferrous Sulfate
    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

    • Diagnostic Test: Follow up ferritin level
    Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.

    Outcome Measures

    Primary Outcome Measures

    1. Change in serum ferritin level [4 weeks]

      Change in serum ferritin level between enrollment and 4 weeks post-treatment.

    Secondary Outcome Measures

    1. Nausea and/or vomiting [4 weeks]

      Incidence of treatment-related nausea and/or vomiting

    2. Dyspepsia [4 weeks]

      Incidence of treatment-related dyspepsia

    3. Compliance to treatment [4 weeks]

      Number of missed doses of treatment from the assigned 30 doses

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain SHams Maternity Hospital Cairo Abbaseya Egypt 002

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ghada Mohamed, MBBCh, G Darwish

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ghada Mohamed Ahmed, Resident of O&G, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03759353
    Other Study ID Numbers:
    • LactvsFerr
    First Posted:
    Nov 30, 2018
    Last Update Posted:
    Nov 30, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anemia, Iron-Deficiency
    Lactoferrin

    Study Results

    No Results Posted as of Nov 30, 2018