Suspended

Effects of Dietary Cholesterol and Cholesterol-Free Regimens on Cholesterol Absorption and Metabolism in Smith-Lemli-Opitz Syndrome

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What is being tested

diet

Behavioral
Who is being recruted

Congenital Abnormalities+13

+ Abnormalities, Multiple

+ Lipid Metabolism, Inborn Errors

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1995
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Study ContactSonja ConnorMore contacts
Last updated: June 24, 2005
Sourced 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.

NCT00004347
Principal SponsorNational Center for Research Resources (NCRR)
Study ContactSonja ConnorMore contacts
Last updated: June 24, 2005
Sourced 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 Maps
SuspendedOne Study Center