Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome
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|ClinicalTrials.gov Identifier: NCT00004347|
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Recruiting
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment||Phase|
|Smith-Lemli-Opitz Syndrome||Behavioral: diet||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Official Title:||The Effects of Dietary Cholesterol in the Smith-Lemli-Opitz Syndrome|
|Study Start Date :||November 1995|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004347
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 97239-3098|
|Contact: Sonja Connor 503-494-7775 firstname.lastname@example.org|
|Contact: Jennifer Penfield 503-494-7944 email@example.com|
|Study Chair:||William Connor||Oregon Health and Science University|