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Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome
This study is currently recruiting participants.
Study NCT00004347   Information provided by National Center for Research Resources (NCRR)
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes

October 18, 1999
June 23, 2005
November 1995
 
 
 
Complete list of historical versions of study NCT00004347 on ClinicalTrials.gov Archive Site
 
 
 
Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome
The Effects of Dietary Cholesterol in the Smith-Lemli-Opitz Syndrome

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.

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.

Phase II
Interventional
Treatment
Smith-Lemli-Opitz Syndrome
Behavioral: diet
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
5
 
 

PROTOCOL ENTRY CRITERIA:

Smith-Lemli-Opitz syndrome

Both
 
No
 
United States
 
NCT00004347
 
NCRR-M01RR00334-0068, OHSU-4019
National Center for Research Resources (NCRR)
Oregon Health and Science University
Study Chair: William Connor Oregon Health and Science University
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP