Clinical trial NCT01417273: Impact of Vitamin A on Multiple Sclerosis (MS)
Official title: Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple sclerosis
immune system
vitamin A
(MSFC)Multiple Sclerosis Functional Composite
(EDSS)Expanded Disability Status Scale
(MRI)Magnetic resonance imaging
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Change from baseline at 12 months
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: Change from baseline at 12 months
measure: fatigue scores
timeFrame: Change from baseline at 12 months
measure: depression score
timeFrame: Change from baseline at 12 months
measure: Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI
timeFrame: Change from baseline at 12 months
Secondary outcomes:
measure: number of disease relapses
timeFrame: Change from baseline at 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences,
Study officials:
affiliation: Tehran University of Medical Sciences
name: Ali Akbar saboor Yaraghi, PhD
role: STUDY_CHAIR
affiliation: Tehran University of Medical Siences
name: Sama Bitarafan, MD, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bitarafan S, Saboor-Yaraghi A, Sahraian MA, Soltani D, Nafissi S, Togha M, Beladi Moghadam N, Roostaei T, Mohammadzadeh Honarvar N, Harirchian MH. Effect of Vitamin A Supplementation on fatigue and depression in Multiple Sclerosis patients: A Double-Blind Placebo-Controlled Clinical Trial. Iran J Allergy Asthma Immunol. 2016 Feb;15(1):13-9.
citation: Bitarafan S, Saboor-Yaraghi A, Sahraian MA, Nafissi S, Togha M, Beladi Moghadam N, Roostaei T, Siassi F, Eshraghian MR, Ghanaati H, Jafarirad S, Rafiei B, Harirchian MH. Impact of Vitamin A Supplementation on Disease Progression in Patients with Multiple Sclerosis. Arch Iran Med. 2015 Jul;18(7):435-40.