Bioavailability of Ubiquinol in Huntington Disease
The death of brain cells in Huntington Disease (HD) is thought to be associated with a lack of normal cell energy and harmful brain substances called free radicals. Coenzyme Q10 (CoQ) is a marketed nutritional supplement that may prove useful in HD because it increases cell energy and combats free radicals. Most studies of CoQ have looked at only one formulation of CoQ ("ubiquinone") in HD. The...
Brief Summary
Official Title: “Bioavailability of Ubiquinol in Huntington Disease”
The death of brain cells in Huntington Disease (HD) is thought to be associated with a lack of normal cell energy and harmful brain substances called free radicals. Coenzyme Q10 (CoQ) is a marketed nutritional supplement that may prove useful in HD because it increases cell energy and combats free radicals.
Most studies of CoQ have looked at only one formulation of CoQ ("ubiquinone") in HD. The purpose of the study is to find out if people that switch from the common formulation of CoQ ("ubiquinone") to a different formulation ("ubiquinol") have higher levels of CoQ in their blood after taking the same dose. The investigators also want to find out if this different formulation is tolerable for individuals with HD.
- Study Type: Interventional
- Study Design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label
- Study Primary Completion Date: March 2010
Intervention(s) in this Clinical Trial
- Dietary Supplement: ubiquinol
- up to 600 mg per day, oral capsules for 8 weeks
Outcome Measures for this Clinical Trial
Primary Measures
- serum coenzyme Q10 levels
- Time Frame: 8 weeks
Safety Issue?: Yes
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Have manifest Huntington disease
- Be 18 years of age or older
- Be taking an oxidized formulation of CoQ for at least 30 days prior to the baseline visit
- Be on a steady dose of all concomitant medications for at least 30 days prior to the baseline visit
Exclusion Criteria:
- Have a history of intolerability of sensitivity to CoQ
- Have an unstable medical or psychiatric illness
- Be pregnant or breastfeeding; women of childbearing age must use reliable contraception
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Rochester Other
Overall Clinical Trial Officials and Contacts
Karl Kieburtz, MD Principal Investigator University of Rochester
Overall Contact: Lisa Deuel 585-276-3987 lisa.deuel@ctcc.rochester.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00980694
Study ID Number: UQ01
ClinicalTrials.gov Identifier: NCT00980694
Health Authority: United States: Institutional Review Board
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00980694
