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

This study is currently recruiting patients.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Oregon Health and Science University
Information provided by: National Center for Research Resources (NCRR)

Purpose

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.

Condition Treatment or Intervention Phase
Cerebrotendinous Xanthomatosis
 Drug: chenodeoxycholic acid
 Drug: lovastatin
Phase II

MedlinePlus related topics:  Genetic Disorders;   Metabolic Disorders;   Skin Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Effects of diet and medication in patients with cerebrotendinous xanthomatosis (CTX)

Further Study Details: 

Expected Total Enrollment:  5

Study start: January 1996

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.

Eligibility

Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis

Location and Contact Information


Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Sonja Connor  503-494-7775 

Study chairs or principal investigators

William Connor,  Study Chair,  Oregon Health and Science University   

More Information

Study ID Numbers:  NCRR-M01RR00334-0067; OHSU-4008
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004346
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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