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

Thalassemia Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02083575
• Other study ID #: vitamin c and iron chelator
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: March 7, 2014
• Last updated: March 7, 2014
• Start date: April 2014
• Est. completion date: April 2014

Study information

• Verified date: March 2014
• Source: Ain Shams University
• Contact: MOHSEN S ELALFY, PROF.
• Email: AMIRADIABETES[@]YAHOO.COM
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Beta-Thalassemia
• Iron Chelation
• Thalassemia
• Thalassemia Major
• Vitamin c

Intervention

Drug:
• Vitamin C, Defriprone, deferisarox
adjuvant vitamin c with iron chelator.
• deferiprone , deferesarox
iron chelator

Locations

Country	Name	City	State
Egypt	Pediatric Hematology clinic, Ain Shams University Egypt	Cairo,

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vit C to Augment iron chelation	assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.	12 months	No
Primary	vitamin c augmenting effect of iron chelator	better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c	12 month	No
Secondary	adverse related events	safety and occurrence of AEs in both studied groups	12 month	No