NCT00065624

Brief Summary

The goal of this study is to determine whether a short treatment with lipoic acid, an antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity and decreases oxidant stress in persons with elevated blood cholesterol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 2, 2007

Status Verified

September 1, 2007

First QC Date

July 29, 2003

Last Update Submit

September 28, 2007

Conditions

Hypercholesterolemia

Keywords

Lipoic acidF2-isoprostanesendothelial dysfunctionnatural product

Interventions

lipoic acidDRUG

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Less than 2 coronary risk factors, and already on a cholesterol-lowering diet.

You may not qualify if:

  • Overt or clinical atherosclerosis
  • Diabetes
  • Currently taking cholesterol-lowering medication.
  • Subjects with other lipid disorders
  • Subjects taking supplemental lipoic acid, vitamin C, or vitamin E.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • James M May, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 29, 2003

First Posted

July 31, 2003

Study Start

November 1, 2003

Study Completion

July 1, 2007

Last Updated

October 2, 2007

Record last verified: 2007-09

Locations

US(1)