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

CompletedNot a drug-phase studyRelapsing MSNCT02463318

What it found

No results found

We found no results in the registry or in papers.

This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Melatonin

    Melatonin receptor agonist

  • Hydrogen peroxide

What it measured

Main measures

  • 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

    Immune response

Other measures (3)

  • MnSOD enzyme activity assay

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

  • Catalse enzyme activity assay

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

  • SIRT1 enzyme activity assay

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

Who could take part

Relapsing MS · 20 to 40

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Sept 2012

      2. Main results due

        Jun 2015

      3. Finished

        Sept 2015

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