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Status unknownNCT02083575Updated Mar 11, 2014

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

A Phase 2/3 interventional study of Vitamin C, Defriprone, deferisarox and deferiprone , deferesarox in Vitamin c, Thalassemia Major and Iron Chelation, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-03-11.

Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Vitamin c
  • Thalassemia Major
  • Iron Chelation

Keywords

  • vitamin c
  • thalassemia major
  • iron chelation
03

In context

Thalassemia

416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.

This study's planned enrollment of 50 is above the median of 37 across 277 interventional studies indexed under Thalassemia.

Browse Thalassemia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • Subjects with overload secondary to thalassemia major

Exclusion criteria

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    vitamin c

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

    Drug: Vitamin C, Defriprone, deferisarox

  • Other
    iron chelator

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

    Drug: deferiprone , deferesarox

Interventions

  • DrugVitamin C, Defriprone, deferisarox

    adjuvant vitamin c with iron chelator.

    Also known as: vitamin c, DFP, DFX

  • Drugdeferiprone , deferesarox

    iron chelator

    Also known as: DFP, DFX

06

What researchers measure

Primary outcomes

  1. Vit C to Augment iron chelation

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

    Time frame: 12 months

  2. vitamin c augmenting effect of iron chelator

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

    Time frame: 12 month

Secondary outcomes

  1. adverse related events

    safety and occurrence of AEs in both studied groups

    Time frame: 12 month

07

Study locations

1 site
  • Pediatric Hematology clinic, Ain Shams University Egypt
    Cairo,, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02083575
Lead sponsor
Ain Shams University
Responsible party
Mohsen Saleh Elalfy (professor, Ain Shams University) — Principal investigator
First posted
Mar 11, 2014
Start date
Apr 2014
Primary completion
Apr 2014 (estimated)
Completion
Apr 2014 (estimated)
Last update
Mar 11, 2014

Study contacts

MOHSEN S ELALFY, PROF.
Contact
AMIRADIABETES@YAHOO.COM
MOHSEN S ELALFY, PROF.
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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