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Trial record 3 of 1116 for:    chelation

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Mohsen Saleh Elalfy, Ain Shams University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02083575
First Posted: March 11, 2014
Last Update Posted: March 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University
  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
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

Resource links provided by NLM:


Further study details as provided by Mohsen Saleh Elalfy, Ain Shams University:

Primary Outcome Measures:
  • Vit C to Augment iron chelation [ Time Frame: 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 [ Time Frame: 12 month ]
    better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c


Secondary Outcome Measures:
  • adverse related events [ Time Frame: 12 month ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 7, 2014
First Posted: March 11, 2014
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Mohsen Saleh Elalfy, Ain Shams University:
vitamin c
thalassemia major
iron chelation

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