Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to study the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and Th1/Th2 balance in patients with Multiple Sclerosis.


Clinical Trial Description

Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFN-g, are believed to play a major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction in MS are believed to become activated outside the central nervous system (CNS) in lymphoid tissue and when they cross the blood brain barrier they will re-encounter their antigen. Immune deviation is the redirection of the immune response from most often Th1 like responses to Th2 like responses, even though the opposite can also occur. 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01225289
Study type Interventional
Source Tehran University of Medical Sciences
Contact
Status Completed
Phase Phase 4
Start date October 2009
Completion date January 2014

See also
  Status Clinical Trial Phase
Completed NCT01945359 - Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design N/A
Completed NCT01450124 - Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) Phase 2
Completed NCT01456416 - Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities Phase 4
Recruiting NCT05277740 - Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
Completed NCT03718247 - Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS
Active, not recruiting NCT03471338 - Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme N/A
Recruiting NCT03004079 - Clinical Importance of Glucose Regulation in Relapsing MS
Terminated NCT02266121 - Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis N/A
Completed NCT01963611 - Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) Phase 2
Active, not recruiting NCT01464905 - Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Phase 3
Recruiting NCT00242268 - A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis Phase 3
Completed NCT00203086 - A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis Phase 4
Completed NCT00616187 - Atorvastatin in Relapsing-Remitting Multiple Sclerosis Phase 2
Recruiting NCT06083753 - Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis Phase 2
Active, not recruiting NCT04602390 - Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis Phase 1
Recruiting NCT06159712 - Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis N/A
Recruiting NCT04604041 - Investigation of Subclinical Markers of Multiple Sclerosis
Terminated NCT03536559 - Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis Phase 2
Completed NCT02490982 - Teriflunomide Observational Effectiveness Study
Withdrawn NCT00939549 - High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis Phase 2