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Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome

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:
NCT00004347
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2003
History of Changes
  Purpose

OBJECTIVES: I. Examine the intestinal absorption of dietary cholesterol in patients with Smith-Lemli-Opitz syndrome.

II. Measure the effect of dietary cholesterol on plasma sterol composition. III. Quantify basal cholesterol synthesis, turnover of cholesterol and 7-dehydrocholesterol, and the effects of dietary cholesterol on these parameters.

IV. Identify fecal bile acid excretion quantitatively and qualitatively in these patients.

V. Compare the incorporation of deuterated water into plasma cholesterol, 7-dehydrocholesterol, and other intermediates, and assess the effect of dietary cholesterol on this incorporation.


Condition Intervention Phase
Smith-Lemli-Opitz Syndrome
 Behavioral: diet
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: The Effects of Dietary Cholesterol in the Smith-Lemli-Opitz Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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

Estimated Enrollment: 5
Study Start Date: November 1995
Detailed Description:

PROTOCOL OUTLINE:

Patients are treated with 2 dietary regimens for 1 to 3 weeks: high cholesterol and cholesterol-free. Cholesterol is provided in the form of egg yolk. The absorption and metabolism of cholesterol are evaluated with plasma and fecal studies. Deuterated water is given to patients followed by analysis of deuterium in plasma cholesterol and other intermediates, including 7-dehydrocholesterol.

  Eligibility

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

PROTOCOL ENTRY CRITERIA:

Smith-Lemli-Opitz syndrome

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004347

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    
Contact: Jennifer Penfield     503-494-7944     penfield@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

No publications provided

ClinicalTrials.gov Identifier: NCT00004347     History of Changes
Other Study ID Numbers: NCRR-M01RR00334-0068, OHSU-4019
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):
Smith-Lemli-Opitz syndrome
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:
Smith-Lemli-Opitz Syndrome
Abnormalities, Multiple
Congenital Abnormalities
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
 Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013