Multiple SclerosisNCT02463318
The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
A study testing Melatonin and Hydrogen peroxide in people with Multiple Sclerosis and Oxidative Stress, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Oxidative Stress
- What is being tested?
- Melatonin and Hydrogen peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIran
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability Status Scale (EDSS) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs.
- -
Who cannot join
- The exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type I and II), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with H2O2.
- Conditions
- Multiple Sclerosis, Oxidative Stress
- Being tested
- Melatonin, Hydrogen peroxide
- Keywords
- Multiple sclerosis, SIRT1, MnSOD, Catalase, Oxidative stress, Antioxidant enzyme
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called N-acetyl-5-methoxy tryptamine
Melatonin is used for healthy subjects and multiple sclerosis patients
Hydrogen peroxideOther
Hydrogen peroxide is only used for healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| Multiple slerosis | Experimental | Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment. Receives: Drug: Melatonin |
| Healthy subjects | Experimental | Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment Receives: Drug: Melatonin; Other: Hydrogen peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative gene expression by real-time PCR (polymerase chain reaction)
Measured: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Secondary outcomes (3)
MnSOD enzyme activity assay
Measured: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Catalse enzyme activity assay
Measured: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
SIRT1 enzyme activity assay
Measured: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Ali Sahraian, Neurologist, Study director, Tehran University of Medical SciencesSolaleh Emamgholipour, PhD Student, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463318
- Sponsor's protocol ID
- 91-01-30-17019
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02463318
- Acronym / sponsor ID
- 91-01-30-17019
- Conditions
- Multiple Sclerosis, Oxidative Stress
- Keywords
- Multiple sclerosis, SIRT1, MnSOD, Catalase, Oxidative stress, Antioxidant enzyme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Jun 2015 (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 purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with H2O2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple slerosis | Experimental | Drug: MelatoninMelatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment. |
| Healthy subjects | Experimental | Drug: Melatonin, Other: Hydrogen peroxideMelatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability Status Scale (EDSS) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs.
- -
Key exclusion criteria (1 listed)
- The exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type I and II), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 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 |
|---|---|---|
| MelatoninAlso: N-acetyl-5-methoxy tryptamineMelatonin is used for healthy subjects and multiple sclerosis patients | Drug | Healthy subjects, Multiple slerosis |
| Hydrogen peroxideHydrogen peroxide is only used for healthy subjects | Other | Healthy subjects |
Primary outcome
Relative gene expression by real-time PCR (polymerase chain reaction)
Time frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
3 secondary outcomes
MnSOD enzyme activity assay
Time frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Catalse enzyme activity assay
Time frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
SIRT1 enzyme activity assay
Time frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for 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.
Mohammad Ali Sahraian, Neurologist study director
Tehran University of Medical Sciences
Solaleh Emamgholipour, PhD Student principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Hydrogen peroxide in people with Multiple Sclerosis and Oxidative Stress, 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 1 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: finished, as of the sponsor's last update on 2 May 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative gene expression by real-time PCR (polymerase chain reaction) (time frame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2). 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 2 May 2017.