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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463318
• Other study ID #: 91-01-30-17019
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Oxidative Stress
• Sclerosis

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