SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Simvastatin
2 Simvastatin capsules of 20 mg every evening for 14 days
Intervention: Simvastatin (Drug)
Placebo
2 placebo capsules every evening for 14 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
Time Frame: Change from Baseline after fourteen days of treatment
Urinary excretion of 8-oxoguanosine (nmol/24h)
Time Frame: Change from Baseline after fourteen days of treatment
Secondary Outcomes
- Malondialdehyde(Change from Baseline after fourteen days of treatment)
- Vitamin C(Change from Baseline after fourteen days of treatment)
- Vitamin E(Change from Baseline after fourteen days of treatment)
- Biopterin(Change from Baseline after fourteen days of treatment)
Investigators
Henrik Enghusen Poulsen
Professor MD
Rigshospitalet, Denmark