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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 March 2023 |
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Main ID: |
NCT01773278 |
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Date of registration:
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03/12/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)
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Scientific title:
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Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS) |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01773278 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Ellen R Elias, MD |
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Address:
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Telephone:
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720 777-5401 |
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Email:
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ellen.elias@childrenscolorado.org |
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Affiliation:
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Name:
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Ellen R Elias, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of Smith-Lemli-Opitz Syndrome
- Elevated levels of 7-dehydrocholesterol and 8-dehydrocholesterol
- Must be able to travel to Children's Hospital Colorado annually
- Must have insurance coverage for ERG/ABR studies
Exclusion Criteria:
- absence of detectable 7-dehydrocholesterol/8-dehydrocholesterol
- allergy to Antioxidant medication
Age minimum:
N/A
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cone-Rod Dystrophy
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Smith-Lemli-Opitz Syndrome
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Hearing Loss
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Intervention(s)
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Drug: Antioxidants
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Drug: Cholesterol
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Primary Outcome(s)
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Change in Electroretinogram (ERG) results over time
[Time Frame: 1-2 year]
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Secondary Outcome(s)
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Change in ABR (Auditory Brainstem response) testing over time
[Time Frame: 1-2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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