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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417273
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tehran University of Medical Sciences
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    fatigue scores on Multiple Sclerosis Fatigue Impact Scale

  • depression score [ Time Frame: Change from baseline at 12 months ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: November 17, 2010
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
Last Verified: August 2011

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