Iron Chelation, Thalassemia Major, Vitamin c
Conditions
Keywords
vitamin c, thalassemia major, iron chelation
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.
Interventions
DRUGVitamin C, Defriprone, deferisarox
adjuvant vitamin c with iron chelator.
DRUGdeferiprone , deferesarox
iron chelator
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vit C to Augment iron chelation | 12 months | 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 | 12 month | better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse related events | 12 month | safety and occurrence of AEs in both studied groups |
Countries
Egypt
Contacts
Primary ContactMOHSEN S ELALFY, PROF.
Outcome results
None listed