At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
crystalline cholesterol oil-based suspensiondrug
Likely dose
crystalline cholesterol oil-based suspension 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of the Cholesterol Defect in Smith-Lemli-Opitz Syndrome
In Brief
A Phase 2 clinical trial evaluating crystalline cholesterol oil-based suspension for Smith-Lemli-Opitz Syndrome. Completed, enrolled 23 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether supplementation with an oil-based cholesterol suspension will correct the biochemical abnormalities in cholesterol and its precursors in individuals with the Smith-Lemli-Opitz syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmith-Lemli-Opitz Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 1998
First PostedJan 2006
Primary CompletionJun 2011
Study CompletionJul 2011
TodayJul 2026
First PostedJan 9, 2006
Enrollment StartJan 1, 1998
Primary CompletionJun 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 13.4 yearsPosted 20.5 years ago
Interventions
crystalline cholesterol oil-based suspensiondrug
200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.