- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004347
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.
Study Overview
Detailed 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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239-3098
- Recruiting
- Oregon Health and Science University
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Contact:
- Sonja Connor
- Phone Number: 503-494-7775
- Email: connors@ohsu.edu
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Contact:
- Jennifer Penfield
- Phone Number: 503-494-7944
- Email: penfield@ohsu.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
Smith-Lemli-Opitz syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: William Connor, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Disease
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Bone Diseases
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Dyslipidemias
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Lipid Metabolism, Inborn Errors
- Bone Diseases, Developmental
- Steroid Metabolism, Inborn Errors
- Penile Diseases
- Craniofacial Dysostosis
- Dysostoses
- Syndrome
- Cleft Palate
- Hypospadias
- Genetic Diseases, X-Linked
- Smith-Lemli-Opitz Syndrome
- Hypertelorism
Other Study ID Numbers
- NCRR-M01RR00334-0068
- OHSU-4019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smith-Lemli-Opitz Syndrome
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