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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
vitamin A
Drug: placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple sclerosis, immune system, vitamin A, (MSFC)Multiple Sclerosis Functional Composite, (EDSS)Expanded Disability Status Scale, (MRI)Magnetic resonance imaging

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tehran University of Medical Sciences,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin A, multiple sclerosis,

placebo/Multiple Sclerosis

Arm Description

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

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day

Outcomes

Primary Outcome Measures

Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease
Multiple Sclerosis Functional Composite (MSFC)
Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease
fatigue scores
fatigue scores on Multiple Sclerosis Fatigue Impact Scale
depression score
depression score on Beck Depression Inventory 2
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

Secondary Outcome Measures

number of disease relapses
To measure the effect of vitamin A supplementation on number of disease relapses

Full Information

First Posted
November 17, 2010
Last Updated
August 12, 2011
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01417273
Brief Title
Impact of Vitamin A on Multiple Sclerosis (MS)
Acronym
MS
Official Title
Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin A, multiple sclerosis,
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo/Multiple Sclerosis
Arm Type
Placebo Comparator
Arm Description
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin A
Intervention Description
1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months
Intervention Type
Drug
Intervention Name(s)
Drug: placebo
Intervention Description
1 cap placebo/day for 12 month
Primary Outcome Measure Information:
Title
Expanded Disability Status Scale (EDSS)
Description
Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease
Time Frame
Change from baseline at 12 months
Title
Multiple Sclerosis Functional Composite (MSFC)
Description
Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease
Time Frame
Change from baseline at 12 months
Title
fatigue scores
Description
fatigue scores on Multiple Sclerosis Fatigue Impact Scale
Time Frame
Change from baseline at 12 months
Title
depression score
Description
depression score on Beck Depression Inventory 2
Time Frame
Change from baseline at 12 months
Title
Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI
Description
Number of active lesion in magnetic resonance imaging (MRI) as a measure of activity and progression of MS disease
Time Frame
Change from baseline at 12 months
Secondary Outcome Measure Information:
Title
number of disease relapses
Description
To measure the effect of vitamin A supplementation on number of disease relapses
Time Frame
Change from baseline at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Akbar saboor Yaraghi, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sama Bitarafan, MD, PhD student
Organizational Affiliation
Tehran University of Medical Siences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences,
City
Tehran
ZIP/Postal Code
School of Public Health
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26996107
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.
Results Reference
derived
PubMed Identifier
26161708
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.
Results Reference
derived

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Impact of Vitamin A on Multiple Sclerosis (MS)

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