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NCT03720990 · ClinicalTrials.gov registry record · Phase 1
Smith-Lemli-Opitz Syndrome and Cholic Acid
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03720990: Completed Phase 1 study, sponsored by University of Nebraska.
NCT03720990 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03720990, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Plasma cholesterol will be measured. Response to cholic acid treatment will consist of a change in plasma cholesterol.
Interventions
- DRUG Cholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-03-27 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 1 |
What the finished NCT03720990 record still lists
NCT03720990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Cholic Acid is the first listed.
NCT03720990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03720990 about?
NCT03720990 is a clinical study titled "Smith-Lemli-Opitz Syndrome and Cholic Acid". 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...
What is the current status of trial NCT03720990?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-03-27. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT03720990?
The interventions under investigation include: Cholic Acid (DRUG).
Who is sponsoring clinical trial NCT03720990?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03720990's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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