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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

February 14, 2011
July 17, 2012
April 2011
April 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01407211 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient
The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
Dietary Supplement: vitamin A

25000 IU/day vitamin A 6 months

1 Cap/Day

1 cap placebo/day for 6 month

  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
September 2013
April 2013   (final data collection date for primary outcome measure)

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. -
Both
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01407211
89/8/18-10033
Yes
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Not Provided
Tehran University of Medical Sciences
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP