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

NCT02083575 | Unknown Phase 2

• 1 other identifier: vitamin c and iron chelator
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin c; Thalassemia Major; Iron Chelation

Keywords

vitamin c; thalassemia major; iron chelation

Outcome Measures

Primary Outcomes (2)

• 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

• vitamin c augmenting effect of iron chelator

  better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c

  12 month

Secondary Outcomes (1)

• adverse related events

  12 month

Study Arms (2)

vitamin c

ACTIVE COMPARATOR

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

Drug: Vitamin C, Defriprone, deferisarox

iron chelator

OTHER

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

Drug: deferiprone , deferesarox

Interventions

Vitamin C, Defriprone, deferisarox DRUG

adjuvant vitamin c with iron chelator.

Also known as: vitamin c, DFP, DFX

vitamin c

deferiprone , deferesarox DRUG

iron chelator

Also known as: DFP, DFX

iron chelator

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects with overload secondary to thalassemia major

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Pediatric Hematology clinic, Ain Shams University Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Ascorbic Acid; Isoflurophate; Deferiprone

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Organofluorophosphonates; Organophosphonates; Organophosphorus Compounds; Pyridones; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• MOHSEN S ELALFY, PROF.

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MOHSEN S ELALFY, PROF.

CONTACT

AMIRADIABETES@YAHOO.COM

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 11, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

EG (1)