Back to resultsPhase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis
Primary Purpose
Cerebrotendinous Xanthomatosis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
chenodeoxycholic acid
lovastatin
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrotendinous Xanthomatosis focused on measuring cerebrotendinous xanthomatosis, inborn errors of metabolism, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis
Sites / Locations
- Oregon Health and Science UniversityRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004346
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00004346
Brief Title
Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis
Official Title
Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Oregon Health and Science University
4. Oversight
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrotendinous Xanthomatosis
Keywords
cerebrotendinous xanthomatosis, inborn errors of metabolism, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
5 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chenodeoxycholic acid
Intervention Type
Drug
Intervention Name(s)
lovastatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Connor
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Chair
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Connor
Phone
503-494-7775
Email
connors@ohsu.edu
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis
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