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

March 7, 2014 updated by: Mohsen Saleh Elalfy, Ain Shams University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo,, Egypt
        • Pediatric Hematology clinic, Ain Shams University Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • DFP
  • vitamin c
  • DFX
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse related events
Time Frame: 12 month
safety and occurrence of AEs in both studied groups
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: MOHSEN S ELALFY, PROF., Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vitamin c and iron chelator

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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