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SIMOX - Induction of Oxidative Stress

NCT02256254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-10

No results posted yet for this study

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.

Conditions

  • Oxidative Stress

Interventions

DRUG

Simvastatin

2 Simvastatin capsules of 20 mg every evening for 14 days

DRUG

Placebo

2 placebo capsules every evening for 14 days

Sponsors & Collaborators

  • Klinisk Biokemisk Afdeling

    collaborator UNKNOWN

  • Klinisk farmakologisk Afdeling

    collaborator UNKNOWN

  • Sektion for Biomedicin Institut for Veterinær Patobiologi

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Henrik Enghusen Poulsen, Professor MD · Department head

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02256254 on ClinicalTrials.gov