Trial record 17 of 99 for:    Atherosclerosis OR arteriosclerosis OR hardening of the arteries | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Thioctic Acid
Antioxidants
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 July 22, 2014