Back to resultsRole of Vitamin C to Augment Iron Chelation With DFP or DFX
Primary Purpose
Vitamin c, Thalassemia Major, Iron Chelation
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin C, Defriprone, deferisarox
deferiprone , deferesarox
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin c focused on measuring vitamin c, thalassemia major, iron chelation
Eligibility Criteria
Inclusion Criteria:
- • Subjects with overload secondary to thalassemia major
Exclusion Criteria:
• with HIV positive or have active HCV.
- A history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema.
- Participation in a previous investigational drug study within the 30 days preceding screening.
- A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding.
- An inability to adhere to the designated procedures and restrictions of this protocol.
Sites / Locations
- Pediatric Hematology clinic, Ain Shams University Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
vitamin c
iron chelator
Arm Description
25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.
Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.
Outcomes
Primary Outcome Measures
Vit C to Augment iron chelation
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
vitamin c augmenting effect of iron chelator
better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c
Secondary Outcome Measures
adverse related events
safety and occurrence of AEs in both studied groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02083575
Brief Title
Role of Vitamin C to Augment Iron Chelation With DFP or DFX
Official Title
Study of Safty and Efficacy of Adjuvant Vitamin c in Augmenting Iron Chelation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
Detailed Description
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin c, Thalassemia Major, Iron Chelation
Keywords
vitamin c, thalassemia major, iron chelation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vitamin c
Arm Type
Active Comparator
Arm Description
25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.
Arm Title
iron chelator
Arm Type
Other
Arm Description
Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.
Intervention Type
Drug
Intervention Name(s)
Vitamin C, Defriprone, deferisarox
Other Intervention Name(s)
vitamin c, DFP, DFX
Intervention Description
adjuvant vitamin c with iron chelator.
Intervention Type
Drug
Intervention Name(s)
deferiprone , deferesarox
Other Intervention Name(s)
DFP, DFX
Intervention Description
iron chelator
Primary Outcome Measure Information:
Title
Vit C to Augment iron chelation
Description
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
Time Frame
12 months
Title
vitamin c augmenting effect of iron chelator
Description
better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c
Time Frame
12 month
Secondary Outcome Measure Information:
Title
adverse related events
Description
safety and occurrence of AEs in both studied groups
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Subjects with overload secondary to thalassemia major
Exclusion Criteria:
• with HIV positive or have active HCV.
A history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema.
Participation in a previous investigational drug study within the 30 days preceding screening.
A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding.
An inability to adhere to the designated procedures and restrictions of this protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MOHSEN S ELALFY, PROF.
Email
AMIRADIABETES@YAHOO.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOHSEN S ELALFY, PROF.
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Hematology clinic, Ain Shams University Egypt
City
Cairo,
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOHSEN S ELALFY, PROF
Email
AMIRADIABETES@YAHOO.COM
First Name & Middle Initial & Last Name & Degree
MOHSEN S ELALFY, PROF
12. IPD Sharing Statement
Learn more about this trial
Role of Vitamin C to Augment Iron Chelation With DFP or DFX
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