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The aim of this study is to study the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and Th1/Th2 balance 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 IFN-g, 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 (VA) or VA-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 inhibits IL 12 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 retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with Multiple Sclerosis/ vitamin A | Active Comparator | Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A |
|
| with Multiple Sclerosis/ placebo | Placebo Comparator | Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin A | Dietary Supplement | 25000 IU/day (one capsule per day) Vitamin A for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation | first day and after 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation | first day and after 6 month | |
| Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation |
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Inclusion Criteria:
Patients who have used interferon beta in last 3 months. Patients with 1-5 EDSS
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Akbar Saboor Yaraghi, PhD | Tehran University of Medical Sciences | Principal Investigator |
| Sima Jafarirad, PhD student | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran University of Medical Sciences, School of Public Health Tehran, Tehran, Iran, Islamic Republic o | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23868508 | Derived | Mohammadzadeh Honarvar N, Harirchian MH, Koohdani F, Siassi F, Abdolahi M, Bitarafan S, Salehi E, Sahraian MA, Eshraghian MR, Saboor-Yarghi AA. The effect of vitamin A supplementation on retinoic acid-related orphan receptor gammat (RORgammat) and interleukin-17 (IL-17) gene expression in Avonex-treated multiple sclerotic patients. J Mol Neurosci. 2013 Nov;51(3):749-53. doi: 10.1007/s12031-013-0058-9. Epub 2013 Jul 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | With Multiple Sclerosis/ Vitamin A | Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A |
| FG001 | With Multiple Sclerosis/ Placebo | Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | With Multiple Sclerosis/ Vitamin A | Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A |
| BG001 | With Multiple Sclerosis/ Placebo | Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation | Posted | Mean | Standard Error | mg/L | first day and after 6 month |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | With Multiple Sclerosis/ Vitamin A | Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MS relapsing | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patien | Tehran University of Medical Sciences | +98 912 2182815 | sjafarirad@gmail.com |
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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 |
| C014794 | retinol palmitate |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Placebo | Drug | 1 capsule per day for six months |
|
| first day and after 6 month |
| Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric) | difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation | first day and after 6 month |
| Tehran University of Medical Sciences, School of Public Health | Tehran | Tehran Province | Iran |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation | Posted | Mean | Standard Error | pg/ml | first day and after 6 month |
|
|
|
| Secondary | Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation | Posted | Mean | Standard Error | ratio | first day and after 6 month |
|
|
|
| Secondary | Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric) | difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation | Posted | Mean | Standard Error | absorbance units | first day and after 6 month |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | With Multiple Sclerosis/ Placebo | Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day | 0 | 17 | 1 | 17 |
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| 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 |