SIMOX - Induction of Oxidative Stress

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02256254

Acronym

SIMOX

Enrollment

Registered

2014-10-03

Start date

2014-09-30

Completion date

2015-02-28

Last updated

2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Oxidative stress, Simvastatin

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.

Interventions

DRUGSimvastatin

2 Simvastatin capsules of 20 mg every evening for 14 days

DRUGPlacebo

2 placebo capsules every evening for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026