Clinical trial NCT02256254: SIMOX - Induction of Oxidative Stress
Official title: SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oxidative Stress
Keywords: Oxidative stress
Simvastatin
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Klinisk Biokemisk Afdeling
name: Klinisk farmakologisk Afdeling
name: Sektion for Biomedicin Institut for Veterinær Patobiologi
First posted: 2014-10-03
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Urinary excretion of 8-oxoguanosine (nmol/24h)
timeFrame: Change from Baseline after fourteen days of treatment
measure: Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
timeFrame: Change from Baseline after fourteen days of treatment
Secondary outcomes:
measure: Malondialdehyde
timeFrame: Change from Baseline after fourteen days of treatment
measure: Vitamin C
timeFrame: Change from Baseline after fourteen days of treatment
measure: Vitamin E
timeFrame: Change from Baseline after fourteen days of treatment
measure: Biopterin
timeFrame: Change from Baseline after fourteen days of treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Department head
name: Henrik Enghusen Poulsen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: