Suspended
Effects of Dietary Cholesterol and Cholesterol-Free Regimens on Cholesterol Absorption and Metabolism in Smith-Lemli-Opitz Syndrome
What is being tested
diet
Behavioral
Who is being recruted
Congenital Abnormalities+13
+ Abnormalities, Multiple
+ Lipid Metabolism, Inborn Errors
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: November 1995
Summary
Principal SponsorNational Center for Research Resources (NCRR)
Study ContactSonja ConnorMore contacts
Last updated: June 24, 2005Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 1995
Actual date on which the first participant was enrolled.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.
Principal SponsorNational Center for Research Resources (NCRR)
Study ContactSonja ConnorMore contacts
Last updated: June 24, 2005Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Congenital AbnormalitiesAbnormalities, MultipleLipid Metabolism, Inborn ErrorsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesSteroid Metabolism, Inborn ErrorsDyslipidemiasLipid Metabolism DisordersSmith-Lemli-Opitz SyndromeGenetic Diseases, InbornRare Diseases
Criteria
PROTOCOL ENTRY CRITERIA: Smith-Lemli-Opitz syndrome
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Oregon Health and Science University
Portland, United StatesOpen Oregon Health and Science University in Google MapsSuspendedOne Study Center