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

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ClinicalTrials.gov Identifier: NCT00004346
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Cerebrotendinous Xanthomatosis Drug: chenodeoxycholic acid Drug: lovastatin Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Primary Purpose: Treatment
Official Title: Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)
Study Start Date : January 1996


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004346


Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Sonja Connor    503-494-7775    connors@ohsu.edu   
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Oregon Health and Science University
Investigators
Study Chair: William Connor Oregon Health and Science University
More Information

ClinicalTrials.gov Identifier: NCT00004346     History of Changes
Other Study ID Numbers: NCRR-M01RR00334-0067
OHSU-4008
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
cerebrotendinous xanthomatosis
inborn errors of metabolism
rare disease

Additional relevant MeSH terms:
Xanthomatosis
Xanthomatosis, Cerebrotendinous
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lovastatin
L 647318
Dihydromevinolin
Chenodeoxycholic Acid
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Cathartics
Gastrointestinal Agents