OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet. II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after...
Date First Received: October 18, 1999
Last Updated: June 23, 2005
Verified by: National Center for Research Resources (NCRR), December 2003
Clinical Trial Phase: Phase 2 | Start Date: January 1996
Overall Status: Recruiting
Estimated Enrollment: 5
Brief Summary
Official Title: “Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)”
Condition Keyword(s):
Intervention(s):
OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet.
II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.
Study Type: Interventional
Study Design: Treatment
Detailed Clinical Trial Description
PROTOCOL OUTLINE: Following a 2-week baseline assessment, patients participate in a feeding study for up to 3 weeks. The diet is free of cholesterol and cholestanol.
For the next 4 weeks, patients return to their typical diet and are medicated with daily lovastatin and chenodeoxycholic acid.
The feeding study is repeated for an additional 3 weeks, with the patient taking either lovastatin or chenodeoxycholic acid.
Intervention(s) in this Clinical Trial
- Drug: chenodeoxycholic acid
- Drug: lovastatin
Criteria for Participation in this Clinical Trial
- PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Center for Research Resources (NCRR)
Overall Clinical Trial Officials and Contacts
William Connor Study Chair Oregon Health and Science University
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004346
Study ID Number: NCRR-M01RR00334-0067
ClinicalTrials.gov Identifier: NCT00004346
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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.
