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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 153 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor 10 versions Re-verified since Aug 9, 2025, no change to tracked fieldsv144-v153
  2. Minor Study description expanded, about 57 wordsv143
  3. Minor 9 versions Re-verified since Nov 22, 2024, no change to tracked fieldsv134-v142
  4. Minor Study Status, Eligibilityv133
  5. Minor Eligibility criteria expanded, about 56 words
    • Study description expanded, about 8 words
    v132
Show 28 earlier versionsHide 28 earlier versions
  1. Minor 9 versions Re-verified since Mar 7, 2023, no change to tracked fieldsv123-v131
  2. Minor Study Status, Study Descriptionv122
  3. Minor 10 versions Re-verified since Jun 27, 2022, no change to tracked fieldsv112-v121
  4. Minor Start date: Oct 13, 2021 to Jun 23, 2021v111
  5. Minor 7 versions Re-verified since Jun 13, 2022, no change to tracked fieldsv104-v110
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05047354
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Smith Lemli Opitz Syndrome, CHILD Syndrome, Lathosterolosis, Desmosterolosis
Related terms Congenital Hemidysplasia with Ichthyosiform Erythroderma and Limb Defects, Desmosterolosis, Lathosterolosis, Smith-Lemli-Opitz Syndrome
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov