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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01407211 |
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Date of registration:
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14/02/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient
MS |
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Scientific title:
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The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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30 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01407211 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Iran, Islamic Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients who have used interferon beta in last 3 months. Patients with 1-5 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
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Health Condition(s) or Problem(s) studied
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Relapsing Remitting Multiple Sclerosis
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Intervention(s)
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Dietary Supplement: vitamin A
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Primary Outcome(s)
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PBMC's prolifration(BrdU colorimetric)
[Time Frame: Change from baseline at 6 months]
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serum HDL cholesterol
[Time Frame: Change from baseline at 6 months]
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complete blood count (CBC)
[Time Frame: Change from baseline at 6 months]
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serum Total cholesterol
[Time Frame: Change from baseline at 6 months]
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serum SGOT concentration
[Time Frame: Change from baseline at 6 months]
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RBP/ TTR ratio
[Time Frame: Change from baseline at 6 months]
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serum SGPT concentration
[Time Frame: Change from baseline at 6 months]
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serum triglycerides level
[Time Frame: Change from baseline at 6 months]
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Secondary Outcome(s)
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gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)
[Time Frame: Change from baseline at 6 months]
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Secondary ID(s)
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89/8/18-10033
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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