Trial record 5 of 5 for:    Antioxidant | Open Studies | Exclude Unknown | NCCAM

The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease

This study is currently recruiting participants.
Verified May 2013 by Oregon State University
Sponsor:
Collaborators:
Oregon Health and Science University
Information provided by (Responsible Party):
Oregon State University
ClinicalTrials.gov Identifier:
NCT00764270
First received: October 1, 2008
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.


Condition Intervention Phase
Atherosclerosis
Dietary Supplement: Crossover of R-alpha lipoic acid and placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of R-alpha Lipoic Acid in Treatment of Atherosclerotic Vascular Disease

Resource links provided by NLM:


Further study details as provided by Oregon State University:

Primary Outcome Measures:
  • hs-CRP [ Time Frame: 12,20 & 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-lso-PGF2a [ Time Frame: 12, 20 & 32 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lipoic acid crossover with placebo
All participants take lipoic acid and placebo in a crossover design with a washout period.
Dietary Supplement: Crossover of R-alpha lipoic acid and placebo
300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of placebo or 300 mg R-alpha-lipoic acid for 12 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction)
  • Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
  • Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
  • On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
  • No tobacco use within 3 months of the study
  • No laboratory evidence of renal, hepatic, or hematological abnormalities
  • Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
  • Elevated levels of urinary and plasma F2-isoprostanes
  • Elevated plasma levels of hs-CRP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764270

Contacts
Contact: Jon Purnell, MD 503-494-1056 purnellj@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97201
Principal Investigator: Jonathan Purnell, MD         
Sponsors and Collaborators
Oregon State University
Oregon Health and Science University
Investigators
Principal Investigator: Balz Frei, PhD Oregon State University
  More Information

No publications provided

Responsible Party: Oregon State University
ClinicalTrials.gov Identifier: NCT00764270     History of Changes
Other Study ID Numbers: AT002034-2, 5P01AT002034
Study First Received: October 1, 2008
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon State University:
atherosclerosis
lipoic acid
thioctic acid
triglycerides
overweight
obesity
oxidative stress
inflammation

Additional relevant MeSH terms:
Antioxidants
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014