Role of Vitamin C to Augment Iron Chelation With DFP or DFX

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02083575

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

Condition or Disease	Intervention/Treatment	Phase
Vitamin c Thalassemia Major Iron Chelation	Drug: Vitamin C, Defriprone, deferisarox Drug: deferiprone , deferesarox	Phase 2/Phase 3

Detailed Description

assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Study of Safty and Efficacy of Adjuvant Vitamin c in Augmenting Iron Chelation

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: vitamin c 25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.	Drug: Vitamin C, Defriprone, deferisarox adjuvant vitamin c with iron chelator. Other Names: vitamin c DFP DFX
Other: iron chelator Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.	Drug: deferiprone , deferesarox iron chelator Other Names: DFP DFX

Arm

Intervention/Treatment

Active Comparator: vitamin c

25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.

Drug: Vitamin C, Defriprone, deferisarox

adjuvant vitamin c with iron chelator.

Other Names:

vitamin c

DFP

DFX

Other: iron chelator

Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.

Drug: deferiprone , deferesarox

iron chelator

Other Names:

DFP

DFX

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

adverse related events [12 month]
safety and occurrence of AEs in both studied groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.