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RECRUITING
NCT01773278
PHASE2

Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation and antioxidant medication. They are carefully monitored with visits to clinic, laboratory testing including cholesterol and 7-dehydrocholesterol levels, vitamin levels, blood counts and liver and kidney function. On a serial basis, no more often than once a year, the patients undergo a series of tests under anesthesia, including electroretinogram (ERG), brainstem audiometry (ABR), and ophthalmologic exam under anesthesia to follow pigmentary retinopathy.

Key Details

Gender

All

Age Range

Any - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2008-12

Completion Date

2025-12

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

DRUG

Antioxidants

Patients will be prescribed the drug DEKAS plus at a dose based on age and weight. The effects of the treatment will be monitored by serial ERG, ABR, oxysterol levels and clinical findings. Blood levels of 25-Oh vitamin D will be monitored to prevent toxicity.

DRUG

Cholesterol

Patients with SLOS typically have cholesterol deficiency. They will be treated with cholesterol supplementation to keep cholesterol levels \> 100 mg/dl if possible

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States