Relapsing Remitting Multiple SclerosisPhase 4MSNCT01417273
Impact of Vitamin A on Multiple Sclerosis (MS)
A Phase 4 study testing vitamin A in people with Relapsing Remitting Multiple Sclerosis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- vitamin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Feb 2010to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have used interferon beta in last 3 months
- Patients with 0-5 EDSS
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences,
Tehran, School of Public Health
About this study
Official title: Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients
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.
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- vitamin A, Drug: placebo
- Keywords
- Multiple sclerosis, immune system, vitamin A, (MSFC)Multiple Sclerosis Functional Composite, (EDSS)Expanded Disability Status Scale, (MRI)Magnetic resonance imaging
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin ADietary supplement
1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months
Drug: placeboDrug
1 cap placebo/day for 12 month
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: vitamin A; Drug: Drug: placebo |
| placebo/Multiple Sclerosis | Placebo comparator | Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day Receives: Dietary Supplement: vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease
Measured: 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
Measured: Change from baseline at 12 months
fatigue scores
fatigue scores on Multiple Sclerosis Fatigue Impact Scale
Measured: Change from baseline at 12 months
depression score
depression score on Beck Depression Inventory 2
Measured: 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
Measured: Change from baseline at 12 months
Secondary outcomes (1)
number of disease relapses
To measure the effect of vitamin A supplementation on number of disease relapses
Measured: Change from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ali Akbar saboor Yaraghi, PhD, Study chair, Tehran University of Medical SciencesSama Bitarafan, MD, PhD student, Principal investigator, Tehran University of Medical Siences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417273
- Sponsor's protocol ID
- 8887
- Acronym
- MS
- Status last verified
- Aug 2011
- First submitted
- 17 Nov 2010
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26996107Bitarafan 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.
PubMed 26161708
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients
- ClinicalTrials.gov ID
- NCT01417273
- Acronym / sponsor ID
- MS / 8887
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin A, multiple sclerosis, | Active comparator | Dietary Supplement: vitamin A, Drug: Drug: placeboPatients 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 | Dietary Supplement: vitamin APatients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who have used interferon beta in last 3 months
- Patients with 0-5 EDSS
Key exclusion criteria (3 listed)
- Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin A1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months | Dietary supplement | placebo/Multiple Sclerosis, vitamin A, multiple sclerosis, |
| Drug: placebo1 cap placebo/day for 12 month | Drug | vitamin A, multiple sclerosis, |
Primary outcome
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
1 secondary outcome
number of disease relapses
Time frame: Change from baseline at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
- Derived from this study: PubMed 26996107Bitarafan 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.
- Derived from this study: PubMed 26161708Bitarafan 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.
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Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Akbar saboor Yaraghi, PhD study chair
Tehran University of Medical Sciences
Sama Bitarafan, MD, PhD student principal investigator
Tehran University of Medical Siences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin A in people with Relapsing Remitting Multiple Sclerosis, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale (EDSS) (time frame: Change from baseline at 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01417273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.