Clinical Trial: Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome
This study is currently recruiting patients.
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||Treatment or Intervention||Phase|
|Smith-Lemli-Opitz Syndrome || Behavior: diet ||Phase II |
MedlinePlus related topics: Birth Defects; Genetic Disorders; Metabolic Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: The effects of dietary cholesterol in the Smith-Lemli-Opitz syndrome
Expected Total Enrollment: 5
Study start: November 1995
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.
Genders Eligible for Study: Both
Location and Contact Information
Oregon Health Sciences University, Portland, Oregon, 97201-3098, United States; Recruiting
William Connor, Study Chair, Oregon Health and Science University
Record last reviewed: December 2003
Last Updated: October 13, 2004
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004347
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005