Relapsing Remitting Multiple SclerosisPhase 4MSNCT01407211
Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient
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 vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient. 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
- 30 participants
- Where
- 1 siteIran
- Study dates
- Apr 2011to Sep 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 1-5 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.
About this study
Official title: The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients
The aim of this study is the comparison between the effects of supplementation with vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS).The most important reason for the limited success obtained in the treatment and prevention so far is most likely related to the limited knowledge about its cause and pathogenesis of MS.One of the recent proposed mechanism for autoimmunity base of MS is Th1/Th2 implance of as well as other inflammatory and anti-inflammatory T cell such as Th17 and Treg and their releasing cytokines. Therefore the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- vitamin A
- Keywords
- multiple sclerosis, Myelin Oligodendrocyte Glycoprotein(MOG), Vitamin A, CD4-Positive T-Lymphocytes, gene expression, Th1 Cells, Th2 Cells
- 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
25000 IU/day vitamin A 6 months
1 Cap/Day
1 cap placebo/day for 6 month
| Study group | Role | What they receive |
|---|---|---|
| with Multiple Sclerosis/ vitamin A | Active comparator | Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A Receives: Dietary Supplement: vitamin A |
| with Multiple Sclerosis/ placebo | 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.
serum Total cholesterol
Measured: Change from baseline at 6 months
serum HDL cholesterol
Measured: Change from baseline at 6 months
serum triglycerides level
Measured: Change from baseline at 6 months
RBP/ TTR ratio
Measured: Change from baseline at 6 months
PBMC's prolifration(BrdU colorimetric)
Measured: Change from baseline at 6 months
complete blood count (CBC)
Measured: Change from baseline at 6 months
serum SGOT concentration
Measured: Change from baseline at 6 months
serum SGPT concentration
Measured: Change from baseline at 6 months
Secondary outcomes (1)
gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407211
- Sponsor's protocol ID
- 89/8/18-10033
- Acronym
- MS
- Status last verified
- Jul 2012
- First submitted
- 14 Feb 2011
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT01407211
- Acronym / sponsor ID
- MS / 89/8/18-10033
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- multiple sclerosis, Myelin Oligodendrocyte Glycoprotein(MOG), Vitamin A, CD4-Positive T-Lymphocytes, gene expression, Th1 Cells, Th2 Cells
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 2 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 vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS).The most important reason for the limited success obtained in the treatment and prevention so far is most likely related to the limited knowledge about its cause and pathogenesis of MS.One of the recent proposed mechanism for autoimmunity base of MS is Th1/Th2 implance of as well as other inflammatory and anti-inflammatory T cell such as Th17 and Treg and their releasing cytokines. Therefore the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with Multiple Sclerosis/ vitamin A | Active comparator | Dietary Supplement: vitamin APatients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A |
| with Multiple Sclerosis/ placebo | 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 (1 listed)
- Patients who have used interferon beta in last 3 months. Patients with 1-5 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
- Patients who have allergy to vitamin A compounds, OR
- Patients who have used vitamin supplements in last 3 months. -
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 A25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month | Dietary supplement | with Multiple Sclerosis/ placebo, with Multiple Sclerosis/ vitamin A |
Primary outcome
serum Total cholesterol
Time frame: Change from baseline at 6 months
serum HDL cholesterol
Time frame: Change from baseline at 6 months
serum triglycerides level
Time frame: Change from baseline at 6 months
RBP/ TTR ratio
Time frame: Change from baseline at 6 months
PBMC's prolifration(BrdU colorimetric)
Time frame: Change from baseline at 6 months
complete blood count (CBC)
Time frame: Change from baseline at 6 months
serum SGOT concentration
Time frame: Change from baseline at 6 months
serum SGPT concentration
Time frame: Change from baseline at 6 months
1 secondary outcome
gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)
Time frame: Change from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
Related trials for Relapsing Remitting Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 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 18 Jul 2012. 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?
serum Total cholesterol (time frame: Change from baseline at 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2012.