Vitamin cPhase 2/3NCT02083575
Role of Vitamin C to Augment Iron Chelation With DFP or DFX
A Phase 2/3 study testing Vitamin C, Defriprone, deferisarox and deferiprone , deferesarox in people with Vitamin c and Thalassemia Major, run by Ain Shams University at 1 site in Egypt.
Trial summary
role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Vitamin c, Thalassemia Major, Iron Chelation
- What is being tested?
- Vitamin C, Defriprone, deferisarox and deferiprone , deferesarox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Apr 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • Subjects with overload secondary to thalassemia major
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
MOHSEN S ELALFY, PROF. contact
Egypt1 site
Pediatric Hematology clinic, Ain Shams University Egypt
Cairo
MOHSEN S ELALFY, PROF, AMIRADIABETES@YAHOO.COM
MOHSEN S ELALFY, PROF
About this study
Official title: 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.
Read the detailed description
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
- Conditions
- Vitamin c, Thalassemia Major, Iron Chelation
- Being tested
- Vitamin C, Defriprone, deferisarox, deferiprone , deferesarox
- Keywords
- vitamin c, thalassemia major, iron chelation
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C, Defriprone, deferisaroxDrug
Also called vitamin c, DFP, DFX
adjuvant vitamin c with iron chelator.
deferiprone , deferesaroxDrug
Also called DFP, DFX
iron chelator
| Study group | Role | What they receive |
|---|---|---|
| vitamin c | Active comparator | 25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator. Receives: Drug: Vitamin C, Defriprone, deferisarox |
| iron chelator | Other | Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator. Receives: Drug: deferiprone , deferesarox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vit C to Augment iron chelation
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
Measured: 12 months
vitamin c augmenting effect of iron chelator
better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c
Measured: 12 month
Secondary outcomes (1)
adverse related events
safety and occurrence of AEs in both studied groups
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin cStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Saleh Elalfy, Ain Shams University
- Investigators
- MOHSEN S ELALFY, PROF., Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083575
- Sponsor's protocol ID
- vitamin c and iron chelator
- Status last verified
- Mar 2014
- First submitted
- 7 Mar 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safty and Efficacy of Adjuvant Vitamin c in Augmenting Iron Chelation
- ClinicalTrials.gov ID
- NCT02083575
- Acronym / sponsor ID
- vitamin c and iron chelator
- Conditions
- Vitamin c, Thalassemia Major, Iron Chelation
- Keywords
- vitamin c, thalassemia major, iron chelation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
Detailed description
assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin c | Active comparator | Drug: Vitamin C, Defriprone, deferisarox25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator. |
| iron chelator | Other | Drug: deferiprone , deferesaroxIncluded 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- • Subjects with overload secondary to thalassemia major
Key exclusion criteria (5 listed)
- • with HIV positive or have active HCV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C, Defriprone, deferisaroxAlso: vitamin c, DFP, DFXadjuvant vitamin c with iron chelator. | Drug | vitamin c |
| deferiprone , deferesaroxAlso: DFP, DFXiron chelator | Drug | iron chelator |
Primary outcome
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
1 secondary outcome
adverse related events
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MOHSEN S ELALFY, PROF. contact
MOHSEN S ELALFY, PROF. principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin C, Defriprone, deferisarox and deferiprone , deferesarox in people with Vitamin c and Thalassemia Major, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOHSEN S ELALFY, PROF. (AMIRADIABETES@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vit C to Augment iron chelation (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.