CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Cholic Aciddrug
Likely dose
Not stated in 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.

Search/NCT03720990
NCT03720990Phase 2Completed
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Smith-Lemli-Opitz Syndrome: A Pilot Study of Cholic Acid Supplementation

University of Nebraska·interventional·Posted Oct 26, 2018·Updated Apr 30, 2024

In Brief

A Phase 2 clinical trial evaluating Cholic Acid for Smith-Lemli-Opitz Syndrome. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine whether dietary cholic acid therapy benefits people with Smith-Lemli-Opitz syndrome (SLOS) by leading to an increase in plasma cholesterol and reduction in harmful cholesterol precursors. SLOS participants will be treated with dietary cholic acid for 8 weeks and plasma cholesterol and cholesterol precursor metabolites will be measured.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmith-Lemli-Opitz Syndrome
CountriesUnited States
CollaboratorsUniversity of Colorado, Denver, Children's Hospital Medical Center, Cincinnati, University of Pittsburgh

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 26, 2018
Enrollment StartMar 27, 2021
Primary CompletionAug 30, 2022
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.7 years ago

Interventions

Cholic Aciddrug

Participants will be treated with cholic acid for 8 weeks