Impact of Vitamin A on Multiple Sclerosis (MS)

Relapsing Remitting Multiple Sclerosis Clinical Trial

— MS  

Official title:

Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01417273
• Other study ID #: 8887
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: November 17, 2010
• Last updated: August 12, 2011
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for next 6 months on disease activity and progression in patients with Multiple Sclerosis.

Description:

Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFNγ, 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 or Vitamin A-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(RA) inhibits IL12 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 RA decreases IFNγ and increases IL5, IL10, and IL4 production.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• vitamin A
1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months

Drug:
• Drug: placebo
1 cap placebo/day for 12 month

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences,	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded Disability Status Scale (EDSS)	Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease	Change from baseline at 12 months	No
Primary	Multiple Sclerosis Functional Composite (MSFC)	Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease	Change from baseline at 12 months	No
Primary	fatigue scores	fatigue scores on Multiple Sclerosis Fatigue Impact Scale	Change from baseline at 12 months	No
Primary	depression score	depression score on Beck Depression Inventory 2	Change from baseline at 12 months	No
Primary	Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI	Number of active lesion in magnetic resonance imaging (MRI) as a measure of activity and progression of MS disease	Change from baseline at 12 months	No
Secondary	number of disease relapses	To measure the effect of vitamin A supplementation on number of disease relapses	Change from baseline at 12 months	No