SIMOX - Induction of Oxidative Stress

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Oxidative Stress

Treatments: Drug: Simvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02256254

2014-647

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Simvastatin

Active Comparator group

Description:

2 Simvastatin capsules of 20 mg every evening for 14 days

Treatment:

Drug: Simvastatin

Placebo

Placebo Comparator group

Description:

2 placebo capsules every evening for 14 days

Treatment:

Drug: Placebo