Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis

Cerebrotendinous Xanthomatosis Clinical Trial

Official title:

Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00004346
• Other study ID #: NCRR-M01RR00334-0067
• Secondary ID: OHSU-4008
• Status: Recruiting
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: January 1996

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older
• Eligibility: PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrotendinous Xanthomatosis
• Xanthomatosis, Cerebrotendinous

Intervention

Drug:
• chenodeoxycholic acid

• lovastatin

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Oregon Health and Science University

Country where clinical trial is conducted

United States,