Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient (MS)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01407211

First received: February 14, 2011

Last updated: July 17, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 14, 2011
Last Updated Date	July 17, 2012
Start Date ^ICMJE	April 2011
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2011)	serum Total cholesterol [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ] serum HDL cholesterol [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ] serum triglycerides level [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ] RBP/ TTR ratio [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ] PBMC's prolifration(BrdU colorimetric) [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ] complete blood count (CBC) [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ] serum SGOT concentration [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ] serum SGPT concentration [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01407211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 30, 2011)	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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient
Official Title ^ICMJE	The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients
Brief Summary	The aim of this study is the comparison between the effects of supplementation with vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient.
Detailed Description	Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS).The most important reason for the limited success obtained in the treatment and prevention so far is most likely related to the limited knowledge about its cause and pathogenesis of MS.One of the recent proposed mechanism for autoimmunity base of MS is Th1/Th2 implance of as well as other inflammatory and anti-inflammatory T cell such as Th17 and Treg and their releasing cytokines. Therefore the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Relapsing Remitting Multiple Sclerosis
Intervention ^ICMJE	Dietary Supplement: vitamin A 25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month
Study Arm (s)	Active Comparator: with Multiple Sclerosis/ vitamin A Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A Intervention: Dietary Supplement: vitamin A Placebo Comparator: with Multiple Sclerosis/ placebo Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day Intervention: Dietary Supplement: vitamin A
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	September 2013
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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. -
Gender	Both
Ages	20 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01407211
Other Study ID Numbers ^ICMJE	89/8/18-10033
Has Data Monitoring Committee	Yes
Responsible Party	Tehran University of Medical Sciences
Study Sponsor ^ICMJE	Tehran University of Medical Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Tehran University of Medical Sciences
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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