Impact of Vitamin A on Multiple Sclerosis (MS) (MS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Dietary supplement: vitamin A; Drug: Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, School of Public Health
    • Tehran University of Medical Sciences,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vitamin A, multiple sclerosis,; Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A for 6 months and 10000 IU/day for next 6 months	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
Placebo Comparator: placebo/Multiple Sclerosis; Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day	Dietary supplement: vitamin A; 1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
fatigue scores	fatigue scores on Multiple Sclerosis Fatigue Impact Scale	Change from baseline at 12 months
depression score	depression score on Beck Depression Inventory 2	Change from baseline at 12 months
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of disease relapses	To measure the effect of vitamin A supplementation on number of disease relapses	Change from baseline at 12 months

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Chair: Ali Akbar saboor Yaraghi, PhD, Tehran University Of Medical Sciences; Principal Investigator: Sama Bitarafan, MD, PhD student, Tehran University of Medical Siences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 16, 2011

Study Record Updates

• Last Update Posted (Estimate): August 16, 2011
• Last Update Submitted That Met QC Criteria: August 12, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Multiple sclerosis; immune system; vitamin A; (MSFC)Multiple Sclerosis Functional Composite; (EDSS)Expanded Disability Status Scale; (MRI)Magnetic resonance imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 8887