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Cholesterol + Antioxidants for Smith-Lemli-Opitz Syndrome
Study Summary
This trial is testing a treatment for patients with a rare genetic disease called Smith-Lemli-Opitz syndrome. The treatment involves giving the patients cholesterol and antioxidant medication, and then carefully monitoring them with regular clinic visits and lab tests. Once a year, the patients also undergo a series of tests under anesthesia, to check for any progression of their disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with Smith-Lemli-Opitz Syndrome.You are allergic to antioxidant medication.Your body does not have detectable levels of 7-dehydrocholesterol or 8-dehydrocholesterol.You have high levels of 7-dehydrocholesterol and 8-dehydrocholesterol in your body.
- Group 1: Antioxidant effect on Oxysterols
- Group 2: antioxidant effects on retinal function
- Group 3: antioxidant effects on hearing
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What does the current medical research say about cholesterol levels and heart health?
"At the moment, there are 5 different clinical trials studying cholesterol. 1 of those is currently in Phase 3 testing. A large number of these trials for cholesterol are based out of one city - Indianapolis, Indiana - but there are a total of 5 locations running these studies."
Are there any available openings for participants in this research?
"Yes, this is an ongoing trial that was posted on December 1st, 2008 and edited most recently on January 4th, 2022. They are recruiting 100 participants from 1 site."
How many individuals are included in this research project?
"That is correct. The information available on clinicaltrials.gov suggests that this particular clinical trial has active recruitment efforts underway. This study was first posted on December 1st, 2008 and received its most recent update on January 4th, 2022. They are looking for 100 patients from a single location to participate in the trial."
What are the FDA's views on cholesterol medications?
"Because a Phase 2 trial only has data supporting safety and none for efficacy, our team rates the cholesterol medication as a 2."
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