SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian
- •healthy men
- •18-50 years
- •BMI: 18-30
排除标准
- •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
研究组 & 干预措施
Simvastatin
2 Simvastatin capsules of 20 mg every evening for 14 days
干预措施: Simvastatin (Drug)
Placebo
2 placebo capsules every evening for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
时间窗: Change from Baseline after fourteen days of treatment
Urinary excretion of 8-oxoguanosine (nmol/24h)
时间窗: Change from Baseline after fourteen days of treatment
次要结局
- 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)
研究者
Henrik Enghusen Poulsen
Professor MD
Rigshospitalet, Denmark