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NCT00004347 Clinical Trial

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

Smith-Lemli-Opitz Syndrome Clinical Trial

Official title:
The Effects of Dietary Cholesterol in the Smith-Lemli-Opitz Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00004347
Other study ID # NCRR-M01RR00334-0068
Secondary ID OHSU-4019
Status Recruiting
Phase Phase 2
First received October 18, 1999
Last updated June 23, 2005
Start date November 1995

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility PROTOCOL ENTRY CRITERIA:

Smith-Lemli-Opitz syndrome

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• diet

Locations
Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Oregon Health and Science University

Country where clinical trial is conducted

United States, 

See also
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Recruiting NCT01773278 - Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS) Phase 2
Completed NCT00070850 - Prenatal Screening For Smith-Lemli-Opitz Syndrome Phase 2