Impact of Vitamin A on Multiple Sclerosis (MS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01417273
First received: November 17, 2010
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Dietary Supplement: vitamin A
Drug: Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Expanded Disability Status Scale (EDSS) [ Time Frame: Change from baseline at 12 months ] [ Designated as safety issue: No ]
    Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease

  • Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: Change from baseline at 12 months ] [ Designated as safety issue: No ]
    Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease

  • fatigue scores [ Time Frame: Change from baseline at 12 months ] [ Designated as safety issue: No ]
    fatigue scores on Multiple Sclerosis Fatigue Impact Scale

  • depression score [ Time Frame: Change from baseline at 12 months ] [ Designated as safety issue: No ]
    depression score on Beck Depression Inventory 2

  • Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI [ Time Frame: Change from baseline at 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline at 12 months ] [ Designated as safety issue: No ]
    To measure the effect of vitamin A supplementation on number of disease relapses


Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417273

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences,
Tehran, Iran, Islamic Republic of, School of Public Health
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Ali Akbar Saboor-Yaraghi/ Assistant professor, Tehran University of Medical Sciences(TUMS)
ClinicalTrials.gov Identifier: NCT01417273     History of Changes
Other Study ID Numbers: 8887
Study First Received: November 17, 2010
Last Updated: August 12, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Multiple sclerosis
immune system
vitamin A
(MSFC)Multiple Sclerosis Functional Composite
(EDSS)Expanded Disability Status Scale
(MRI)Magnetic resonance imaging

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014