Vitamin C Chelation Therapy
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | April 2014 |
| Estimated Primary Completion Date : | April 2014 |
| Estimated Study Completion Date : | April 2014 |
Resource links provided by the National Library of Medicine 
| 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:
|
| iron chelator Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator. | Drug: deferiprone , deferesarox iron chelator Other Names:
|
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
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.
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
Locations
| Egypt | |
| Pediatric Hematology clinic, Ain Shams University Egypt | |
| 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 |
| Responsible Party: | Mohsen Saleh Elalfy, professor, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT02083575 |
| Other Study ID Numbers: | vitamin c and iron chelator |
| First Posted: | March 11, 2014 Key Record Dates |
| 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:
| Thalassemia beta-Thalassemia Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Vitamins Ascorbic Acid | Deferiprone Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Iron Chelating Agents Chelating Agents Sequestering Agents |
Source: https://clinicaltrials.gov/ct2/show/NCT02083575
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