Trial record 3 of 648 for:    chelation

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

This study is not yet open for participant recruitment.
Verified March 2014 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University
ClinicalTrials.gov Identifier:
NCT02083575
First received: March 7, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study of Safty and Efficacy of Adjuvant Vitamin c in Augmenting Iron Chelation

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Vit C to Augment iron chelation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c


Secondary Outcome Measures:
  • adverse related events [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    safety and occurrence of AEs in both studied groups


Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02083575

Contacts
Contact: MOHSEN S ELALFY, PROF. AMIRADIABETES@YAHOO.COM

Locations
Egypt
Pediatric Hematology clinic, Ain Shams University Egypt Not yet recruiting
Cairo,, Egypt
Contact: MOHSEN S ELALFY, PROF       AMIRADIABETES@YAHOO.COM   
Principal Investigator: MOHSEN S ELALFY, PROF         
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: MOHSEN S ELALFY, PROF. Ain Shams University
  More Information

No publications provided

Responsible Party: Mohsen Saleh Elalfy, professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT02083575     History of Changes
Other Study ID Numbers: vitamin c and iron chelator
Study First Received: March 7, 2014
Last Updated: March 7, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
vitamin c
thalassemia major
iron chelation

Additional relevant MeSH terms:
Chelating Agents
Iron Chelating Agents
Beta-Thalassemia
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Ascorbic Acid
Vitamins
Iron
Deferiprone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Trace Elements

ClinicalTrials.gov processed this record on April 17, 2014