Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004346
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Study of Cholesterol- and Cholestanol-Free Diet Lovastatin and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis CTX
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OHSU-4008 | None | None | None |