RecruitingNCT05047354

Biochemical and Phenotypical Aspects of Smith-Lemli-Opitz Syndrome and Related Disorders of Cholesterol Metabolism

Natural History Investigation Into Biochemical and Phenotypical Aspects of Smith-Lemli-Opitz Syndrome and Related Disorders of Cholesterol Metabolism


Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Enrollment

250 participants

Start Date

Jun 23, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Smith-Lemli-Opitz Syndrome (SLOS) is a genetic disorder. It can cause birth defects and developmental delays. There is no cure for SLOS or other inherited diseases related to cholesterol production or storage. The data gained in this study may help researchers find ways to measure how well future treatments work. Objective: To learn more about SLOS and related disorders and how these diseases affect participants and relatives. Eligibility: People of any age who have or are suspected to have SLOS or another inherited disease related to cholesterol production or storage. Relatives are also needed. Design: Participants will be screened with a medical record review. Participants will have visits every 6 to 12 months. They will have a physical exam. They will fill out a survey about their medical and behavioral history. They may have an eye exam. They may have a neurodevelopmental assessment. They may have a hearing test. Their outer and middle ears may be examined. Their ability to speak, understand speech, eat, and swallow may be assessed. They may get X-rays while they chew and swallow. Their functional ability and needs for adaptive devices or braces may be assessed. They may have a lumbar puncture. Photographs may be taken of their face and body. Participants who cannot visit the NIH and relatives will have a virtual visit once a year. They will talk about their medical history and symptoms. They give blood, urine, and skin samples at a lab near their home. They will fill out a survey about their medical and behavioral history. Participation will last for several years.


Eligibility

Min Age: 1 DayMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This NIH study examines Smith-Lemli-Opitz Syndrome (SLOS) and related inherited disorders of cholesterol metabolism — rare conditions where the body cannot make or process cholesterol properly. Researchers study patients, family members, and carriers to better understand these diseases and look for better treatments. You may be eligible if: - You (or your child) have a confirmed or suspected diagnosis of SLOS or a related cholesterol synthesis disorder (e.g., desmosterolosis, CHILD syndrome) - You are a biological parent or known carrier of one of these conditions - You are willing to provide biological samples (blood, urine, possibly a skin biopsy) - There is no minimum or maximum age requirement You may NOT be eligible for on-site participation if: - Your medical condition prevents travel to the NIH - The investigator believes your participation would pose medical risk - You are a carrier adult who is unwilling to provide any biological samples - You are pregnant and would need sedation, radiation, or a lumbar puncture (though remote and blood-only participation may still be possible) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05047354


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