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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

Primary Purpose

Multiple Sclerosis, Oxidative Stress

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Melatonin

Hydrogen peroxide

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring Multiple sclerosis, SIRT1, MnSOD, Catalase, Oxidative stress, Antioxidant enzyme

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Solaleh Emamgholipour

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Multiple slerosis

Healthy subjects

Arm Description

Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment.

Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment

Outcomes

Primary Outcome Measures

Relative gene expression by real-time PCR (polymerase chain reaction)

Secondary Outcome Measures

MnSOD enzyme activity assay

Catalse enzyme activity assay

SIRT1 enzyme activity assay

Full Information

NCT ID

NCT02463318

First Posted

June 2, 2015

Last Updated

April 30, 2017

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02463318

Brief 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Oxidative Stress

Keywords

Multiple sclerosis, SIRT1, MnSOD, Catalase, Oxidative stress, Antioxidant enzyme

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multiple slerosis

Arm Type

Experimental

Arm Description

Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment.

Arm Title

Healthy subjects

Arm Type

Experimental

Arm Description

Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment

Intervention Type

Drug

Intervention Name(s)

Melatonin

Other Intervention Name(s)

N-acetyl-5-methoxy tryptamine

Intervention Description

Melatonin is used for healthy subjects and multiple sclerosis patients

Intervention Type

Other

Intervention Name(s)

Hydrogen peroxide

Intervention Description

Hydrogen peroxide is only used for healthy subjects

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

MnSOD enzyme activity assay

Time Frame

Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

Title

Catalse enzyme activity assay

Time Frame

Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

Title

SIRT1 enzyme activity assay

Time Frame

Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. - Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad Ali Sahraian, Neurologist

Organizational Affiliation

Tehran University of Medical Sciences

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Solaleh Emamgholipour, PhD Student

Organizational Affiliation

Tehran University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Solaleh Emamgholipour

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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