Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis
Recruitment status was: Recruiting
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.
|Cerebrotendinous Xanthomatosis||Drug: chenodeoxycholic acid Drug: lovastatin||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)|
|Study Start Date:||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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004346
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 97239-3098|
|Contact: Sonja Connor 503-494-7775 firstname.lastname@example.org|
|Study Chair:||William Connor||Oregon Health and Science University|