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NCT01356420 · ClinicalTrials.gov registry record · NA
Sterol and Isoprenoid Disease Research Consortium: Smith-Lemli-Opitz Syndrome
A NA study, sponsored by Oregon Health and Science University.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT01356420: Clinical Trial NA study, sponsored by Oregon Health and Science University.
NCT01356420 is a NA study that was terminated before completion, run by Oregon Health and Science University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01356420, a NA study, was terminated before completion, sponsored by Oregon Health and Science University.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about Smith-Lemli-Opitz Syndrome (SLOS). SLOS is an inherited condition that is caused by the body not making an enzyme as it should. The body needs the enzyme to help make cholesterol. SLOS can cause many health problems including slow growth and development, eating disorders, sleep disorders, behavior disorders, and eye diseases. Severe SLOS leads to birth defects and mental retardation and in many cases early death. The investigators plan to measure cholesterol and other sterol levels, perform clinical observations, whole body testing and imaging (brain MRIs), to learn more about the disease and its progression, differences in the clinical features among individuals with SLOS, and look at the effect of cholesterol supplementation in this condition. The study is an interventional study to characterize disease progression and correlations between clinical, biochemical and physiological features of the disease. The main hypothesis is that dietary cholesterol supplementation does not improve features of SLOS related to the brain (e.g. IQ, behavior).
Primary Outcome
This study will measure changes in whole body cholesterol pool size, 24S, cholesterol absorption and synthesis in relation with cholesterol intake and changes in clincal end-points.
Interventions
- DIETARY_SUPPLEMENT Cholesterol supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-12 |
| Phase | NA |
Why NCT01356420 stopped before completion
NCT01356420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Cholesterol supplementation is the first listed.
NCT01356420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01356420 about?
NCT01356420 is a clinical study titled "Sterol and Isoprenoid Disease Research Consortium: Smith-Lemli-Opitz Syndrome". The purpose of this study is to learn about Smith-Lemli-Opitz Syndrome (SLOS). SLOS is an inherited condition that is caused by the body not making an enzyme as it should. The body needs the enzyme to help make cholesterol. SLOS can cause many health problems including slow growth and development, e...
What is the current status of trial NCT01356420?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2011-01. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01356420?
The interventions under investigation include: Cholesterol supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01356420?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01356420's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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