Back to resultsLactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy
Primary Purpose
Iron Deficiency Anemia of Pregnancy
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lactoferrin
ferrous sulphate + folic acid (vitamin B9)
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy focused on measuring iron deficiency anemia of pregnancy - lactoferrin
Eligibility Criteria
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)
Sites / Locations
- Ain Shams Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lactoferrin
ferrous sulphate + folic acid (vitamin B9)
Arm Description
100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.
150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.
Outcomes
Primary Outcome Measures
Hemoglobin (Hb) level.
to be measured before and after treatment.
Secondary Outcome Measures
serum ferritin level.
to be measured before and after treatment.
Full Information
NCT ID
NCT03481790
First Posted
March 12, 2018
Last Updated
March 22, 2018
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03481790
Brief Title
Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 5, 2018 (Actual)
Study Completion Date
March 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy
Keywords
iron deficiency anemia of pregnancy - lactoferrin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactoferrin
Arm Type
Experimental
Arm Description
100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.
Arm Title
ferrous sulphate + folic acid (vitamin B9)
Arm Type
Experimental
Arm Description
150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.
Intervention Type
Drug
Intervention Name(s)
Lactoferrin
Other Intervention Name(s)
Pravotin, MamyVital
Intervention Description
(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
ferrous sulphate + folic acid (vitamin B9)
Other Intervention Name(s)
Ferrofol
Intervention Description
(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.
Primary Outcome Measure Information:
Title
Hemoglobin (Hb) level.
Description
to be measured before and after treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
serum ferritin level.
Description
to be measured before and after treatment.
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mamdouh
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy
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