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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

October 18, 1999
June 23, 2005
November 1995
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Complete list of historical versions of study NCT00004347 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 2
Primary Purpose: Treatment
Smith-Lemli-Opitz Syndrome
Behavioral: diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
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PROTOCOL ENTRY CRITERIA:

Smith-Lemli-Opitz syndrome

Both
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No
United States
 
NCT00004347
NCRR-M01RR00334-0068, OHSU-4019
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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