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Completed

NCT Number: NCT02463318

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Oxidative Stress

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Solaleh Emamgholipour

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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.

Treatment and study plan

Melatonin

Drug

Melatonin is used for healthy subjects and multiple sclerosis patients

Other names: N-acetyl-5-methoxy tryptamine

Hydrogen peroxide

Other

Hydrogen peroxide is only used for healthy subjects

Primary outcomes

  1. 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 outcomes

  1. MnSOD enzyme activity assay

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

  2. Catalse enzyme activity assay

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

  3. SIRT1 enzyme activity assay

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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2015
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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