Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00764270
Recruitment Status : Active, not recruiting
First Posted : October 2, 2008
Last Update Posted : March 3, 2020
Sponsor:
Collaborators:
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gerd Bobe, Oregon State University

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date March 3, 2020
Study Start Date  ICMJE August 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
hs-CRP [ Time Frame: 12,20 & 32 weeks ]
High sensitive C-reactive protein
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
hs-CRP [ Time Frame: 12,20 & 32 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
8-lso-PGF2a [ Time Frame: 12, 20 & 32 weeks ]
8-iso-prostaglandin F2alpha
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
8-lso-PGF2a [ Time Frame: 12, 20 & 32 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Official Title  ICMJE The Role of R-alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE Dietary Supplement: R-alpha lipoic acid
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 the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks
Study Arms  ICMJE
  • Active Comparator: Lipoic acid treatment
    Participants take lipoic acid with a washout period before or after placebo.
    Intervention: Dietary Supplement: R-alpha lipoic acid
  • Placebo Comparator: Placebo treatment
    Participants take placebo with a washout period before or after lipoic acid treatment
    Intervention: Dietary Supplement: R-alpha lipoic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764270
Other Study ID Numbers  ICMJE AT002034-2 (7187)
5P01AT002034 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerd Bobe, Oregon State University
Study Sponsor  ICMJE Oregon State University
Collaborators  ICMJE
  • Oregon Health and Science University
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Gerd Bobe, PhD Oregon State University
PRS Account Oregon State University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP