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Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03481790
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
6.1
Actual Duration (Months)
32.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy.

Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.

Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.

Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Mar 5, 2018
Actual Study Completion Date :
Mar 5, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lactoferrin

100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.

Drug: Lactoferrin
(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.
Other Names:
  • Pravotin
  • MamyVital

    		•
    Experimental: ferrous sulphate + folic acid (vitamin B9)

    150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.

    Drug: ferrous sulphate + folic acid (vitamin B9)
    (Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.
    Other Names:
  • Ferrofol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hemoglobin (Hb) level. [4 weeks]

      to be measured before and after treatment.

    Secondary Outcome Measures

    1. serum ferritin level. [4 weeks]

      to be measured before and after treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pregnant women with single fetus

    • Hb count < 11g/dL

    • ferritin level < 12 ng/dL

    • Gestational age (14 - 30 weeks)

    Exclusion Criteria:

    • Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).

    • Associated bleeding disorder

    • Anaemia requiring blood tranfusion (Hb < 7g/dL)

    • Hypersensitivity to iron preparations

    • Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams Maternity Hospital Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams Maternity Hospital

    Investigators

    • Study Director: Ahmed Mamdouh, Ain Shams Maternity Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Khaled Mohamed Balsha, principal investigator, Ain Shams Maternity Hospital
    ClinicalTrials.gov Identifier:
    NCT03481790
    Other Study ID Numbers:
    • AinShams Maternity Hospital
    First Posted:
    Mar 29, 2018
    Last Update Posted:
    Mar 29, 2018
    Last Verified:
    Mar 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
    Keywords provided by Khaled Mohamed Balsha, principal investigator, Ain Shams Maternity Hospital
    iron deficiency anemia of pregnancy - lactoferrin
    Additional relevant MeSH terms:
    Anemia
    Anemia, Iron-Deficiency
    Deficiency Diseases
    Folic Acid
    Lactoferrin

    Study Results

    No Results Posted as of Mar 29, 2018