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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin A, multiple sclerosis, | Active Comparator | 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 |
|
| placebo/Multiple Sclerosis | Placebo Comparator | Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin A | Dietary Supplement | 1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
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| Name | Affiliation | Role |
|---|---|---|
| Ali Akbar saboor Yaraghi, PhD | Tehran University of Medical Sciences | Study Chair |
| Sama Bitarafan, MD, PhD student | Tehran University of Medical Siences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran University of Medical Sciences, | Tehran | School of Public Health | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26996107 | Derived | 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. | |
| 26161708 |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Drug: placebo | Drug | 1 cap placebo/day for 12 month |
|
| 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |