Back to resultsBovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy
Primary Purpose
Anemia During Pregnancy
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
L (lactoferrin)
F (ferrous sulphate)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia During Pregnancy focused on measuring lactoferrin, iron deficiency anemia in pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant with singleton intrauterine pregnancy
- 14- 20 weeks of gestation
- Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.
Exclusion Criteria:
- Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait).
- Hemoglobin less than 9 g/dL.
- Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities.
- History of acid-peptic disorders, esophagitis, or hiatal hernia.
- Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
- Medical disorders with pregnancy.
- Bleeding in early pregnancy.
- Allergies to milk proteins / hypersensitivity to iron preparations.
- History of ingestion of any hematinics within the last 1 month before study entry.
- Recent blood transfusion.
- Refusal to participate in the study.
Sites / Locations
- Mai Mahmoud MohamedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
L (lactoferrin in IDA with pregnancy)
F (ferrous sulphate with pregnancy)
Arm Description
Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 100 mg bLf granules (Pravotin sachets , Hygint, Egypt) in 1/4 glass of water twice a day before meals in addition to placebo tablets three time per day on an empty stomach.
Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, Eipico, Egypt), one capsule three times daily on an empty stomach, at least 1 hour before or 2 hours after meals, in addition to placebo sachets (starch) twice a day.
Outcomes
Primary Outcome Measures
change in Hemoglobin concentration
grams/dL
Secondary Outcome Measures
Serum ferritin
nanograms per milliliter
mean cell volume (MCV)
fL/red cell in adult
mean corpuscular hemoglobin (MCH)
picograms (pg)/cell in adults
mean cell hemoglobin concentration (MCHC)
g/dL
cost
The average drug cost by LE.
percentage of women who agree to take each of the two drugs for a future whole pregnancy.
percentage
Side effects:
scaling score of side effects of oral administration of bLf and ferrous sulfate as:
gastrointestinal discomfort
nausea
heart burn
constipation The degree of side effects will be assessed using objective scaling scoring system: 0 (no symptoms), 1 (mild not requiring any change in life style), 2 (severe controlled with another method), 3 (severe not controlled but accepting), 4 (severe not controlled and not accepting).
Full Information
NCT ID
NCT03202615
First Posted
December 6, 2015
Last Updated
July 5, 2018
Sponsor
Abdelwahed, Mai Mahmoud Mohamed, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT03202615
Brief Title
Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy
Official Title
Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abdelwahed, Mai Mahmoud Mohamed, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.
Detailed Description
The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia During Pregnancy
Keywords
lactoferrin, iron deficiency anemia in pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L (lactoferrin in IDA with pregnancy)
Arm Type
Experimental
Arm Description
Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 100 mg bLf granules (Pravotin sachets , Hygint, Egypt) in 1/4 glass of water twice a day before meals in addition to placebo tablets three time per day on an empty stomach.
Arm Title
F (ferrous sulphate with pregnancy)
Arm Type
Active Comparator
Arm Description
Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, Eipico, Egypt), one capsule three times daily on an empty stomach, at least 1 hour before or 2 hours after meals, in addition to placebo sachets (starch) twice a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
L (lactoferrin)
Other Intervention Name(s)
Pravotin sachets
Intervention Description
Dietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets
Intervention Type
Drug
Intervention Name(s)
F (ferrous sulphate)
Other Intervention Name(s)
Ferrofol capsules
Intervention Description
Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.
Primary Outcome Measure Information:
Title
change in Hemoglobin concentration
Description
grams/dL
Time Frame
At time 0 (enrollment),1 and 2 months
Secondary Outcome Measure Information:
Title
Serum ferritin
Description
nanograms per milliliter
Time Frame
At time 0 (enrollment) and 2 months
Title
mean cell volume (MCV)
Description
fL/red cell in adult
Time Frame
At time 0 (enrollment) and 2 months
Title
mean corpuscular hemoglobin (MCH)
Description
picograms (pg)/cell in adults
Time Frame
At time 0 (enrollment) and 2 months
Title
mean cell hemoglobin concentration (MCHC)
Description
g/dL
Time Frame
At time 0 (enrollment) and 2 months
Title
cost
Description
The average drug cost by LE.
Time Frame
1-2 months
Title
percentage of women who agree to take each of the two drugs for a future whole pregnancy.
Description
percentage
Time Frame
At time 0 (enrollment) and every 2 weeks, for 2 months
Title
Side effects:
Description
scaling score of side effects of oral administration of bLf and ferrous sulfate as:
gastrointestinal discomfort
nausea
heart burn
constipation The degree of side effects will be assessed using objective scaling scoring system: 0 (no symptoms), 1 (mild not requiring any change in life style), 2 (severe controlled with another method), 3 (severe not controlled but accepting), 4 (severe not controlled and not accepting).
Time Frame
At time 0 (enrollment) and every 2 weeks, for 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant with singleton intrauterine pregnancy
14- 20 weeks of gestation
Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.
Exclusion Criteria:
Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait).
Hemoglobin less than 9 g/dL.
Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities.
History of acid-peptic disorders, esophagitis, or hiatal hernia.
Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
Medical disorders with pregnancy.
Bleeding in early pregnancy.
Allergies to milk proteins / hypersensitivity to iron preparations.
History of ingestion of any hematinics within the last 1 month before study entry.
Recent blood transfusion.
Refusal to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai M Abdelwahed, specialist
Phone
01152684127
Ext
002
Email
maya_mohamed0@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gihan E El Hawwary, specialist
Phone
01210333986
Ext
002
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif A Ashoush, a. professor
Organizational Affiliation
personal
Official's Role
Study Chair
Facility Information:
Facility Name
Mai Mahmoud Mohamed
City
Alexandria
ZIP/Postal Code
12345
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Ms Abdelwahed, Master
Phone
01152684127
Ext
002
Email
maya_mohamed0@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sherif Mr Ashoush, Doctoral
Phone
01222660266
Ext
002
Email
sherifashoush@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy
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