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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004346
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2003
  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 Intervention Phase
Cerebrotendinous Xanthomatosis
Drug: chenodeoxycholic acid
Drug: lovastatin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 5
Study Start Date: January 1996
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Oregon Health and Science University
Investigators
Study Chair: William Connor Oregon Health and Science University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004346     History of Changes
Other Study ID Numbers: NCRR-M01RR00334-0067, OHSU-4008
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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
Chenodeoxycholic Acid
Lovastatin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cathartics
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 22, 2014