|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01705457 |
|
Date of registration:
|
09/10/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis
RAR |
|
Scientific title:
|
Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients |
|
Date of first enrolment:
|
February 2010 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
http://clinicaltrials.gov/show/NCT01705457 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Iran, Islamic Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Sama Bitarafan, MD, PhD student |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tehran University of Medical Siences |
|
|
Name:
|
Ali Akbar saboor Yaraghi, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tehran University of Medical Sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients who have used interferon beta in last 3 months.
- Patients with 0-5 EDSS
Exclusion Criteria:
- Patients who have diseases which affect on Th1/Th2 balance such as asthma, active
viral infections, and autoimmune diseases, OR
- Patients who have allergy to vitamin A compounds, OR
- Patients who have used vitamin supplements in last 3 months.
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Relapsing Remitting Multiple Sclerosis
|
|
Intervention(s)
|
|
Drug: Dietary Supplement: vitamin A
|
|
Drug: placebo
|
|
Primary Outcome(s)
|
|
Gene expression of RAR(Relative quantification)
[Time Frame: Change from baseline at 6 months]
|
|
Secondary ID(s)
|
|
91-03-161-19476
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|