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Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

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ClinicalTrials.gov Identifier: NCT03759353
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada Mohamed Ahmed, Ain Shams University

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
Iron Deficiency Anemia Diagnostic Test: Baseline ferritin level Drug: Lactoferrin Drug: Ferrous Sulfate Diagnostic Test: Follow up ferritin level Phase 2

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Study Type : Interventional  (Clinical Trial)
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 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 : January 15, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Change in serum ferritin level [ Time Frame: 4 weeks ]
    Change in serum ferritin level between enrollment and 4 weeks post-treatment.


Secondary Outcome Measures :
  1. Nausea and/or vomiting [ Time Frame: 4 weeks ]
    Incidence of treatment-related nausea and/or vomiting

  2. Dyspepsia [ Time Frame: 4 weeks ]
    Incidence of treatment-related dyspepsia

  3. Compliance to treatment [ Time Frame: 4 weeks ]
    Number of missed doses of treatment from the assigned 30 doses



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759353


Locations
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Egypt
Ain SHams Maternity Hospital
Cairo, Abbaseya, Egypt, 002
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ghada Mohamed, MBBCh G Darwish

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Responsible Party: Ghada Mohamed Ahmed, Resident of O&G, Ain Shams University
ClinicalTrials.gov Identifier: NCT03759353     History of Changes
Other Study ID Numbers: LactvsFerr
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Lactoferrin
Anti-Infective Agents