SIMOX - Induction of Oxidative Stress

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.

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

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simvastatin<br>2 Simvastatin capsules of 20 mg every evening for 14 days | Drug: Simvastatin<br>* 2 Simvastatin capsules of 20 mg every evening for 14 days<br>|
| Placebo Comparator: Placebo<br>2 placebo capsules every evening for 14 days | Drug: Placebo<br>* 2 placebo capsules every evening for 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary excretion of 8-oxoguanosine (nmol/24h) |  | Change from Baseline after fourteen days of treatment | 
| Urinary excretion of 8-oxodeoxyguanosine (nmol/24h) |  | Change from Baseline after fourteen days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxidative stress, Simvastatin