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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02463318
Other study ID # 91-01-30-17019
Secondary ID
Status Completed
Phase N/A
First received June 2, 2015
Last updated April 30, 2017
Start date September 2012
Est. completion date September 2015

Study information

Verified date June 2015
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date September 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Melatonin
Melatonin is used for healthy subjects and multiple sclerosis patients
Other:
Hydrogen peroxide
Hydrogen peroxide is only used for healthy subjects

Locations

Country Name City State
Iran, Islamic Republic of Solaleh Emamgholipour Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relative gene expression by real-time PCR (polymerase chain reaction) Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Secondary MnSOD enzyme activity assay Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Secondary Catalse enzyme activity assay Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Secondary SIRT1 enzyme activity assay Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
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