SIMOX - Induction of Oxidative Stress

Oxidative Stress Clinical Trial

— SIMOX  

Official title:

SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256254
• Other study ID #: 2014-647
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2014
• Last updated: March 9, 2015
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a group treated with simvastatin with the change in a placebo group. The study is a randomized-based, double-blinded placebo-controlled study. Each treatment group consists of 20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Caucasian

• healthy men

• 18-50 years

• BMI: 18-30

Exclusion Criteria:

• Total cholesterol less than 3 mmol/L

• Use of natural and herbal medicines that is affected/affects simvastatin:

anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole, rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole

• following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase deficiency l Glucose/galactose-malabsorption m Psychiatric disorder

• allergies towards any of the tested medicine

• intake of narcotics within 2 months prior to trial

• intake of supplements within 2 months prior to trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Drug:
• Simvastatin
2 Simvastatin capsules of 20 mg every evening for 14 days
• Placebo
2 placebo capsules every evening for 14 days

Locations

Country	Name	City	State
Denmark	Department of Clinical Pharmacology	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Klinisk Biokemisk Afdeling, Klinisk farmakologisk Afdeling, Sektion for Biomedicin Institut for Veterinær Patobiologi

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary excretion of 8-oxoguanosine (nmol/24h)		Change from Baseline after fourteen days of treatment	No
Primary	Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)		Change from Baseline after fourteen days of treatment	No
Secondary	Malondialdehyde		Change from Baseline after fourteen days of treatment	No
Secondary	Vitamin C		Change from Baseline after fourteen days of treatment	No
Secondary	Vitamin E		Change from Baseline after fourteen days of treatment	No
Secondary	Biopterin		Change from Baseline after fourteen days of treatment	No