Trial · NCT01434745
SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation
NCT01434745, Not applicable, Terminated, Oregon Health and Science University; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation. Trials, record NCT01434745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01434745
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation
- NCT number
- NCT01434745
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 1 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Smith-Lemli-Opitz Syndrome
- Interventions
- Simvastatin, Lactose
- First posted
- 2011-09-15
- Last updated
- 2019-10-01
- Results first posted
- 2019-10-01
- Limitations and caveats
- Analyses were not completed and will never be completed due to insufficient funding
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Development Quotient (DQ) | through study completion, an average of 2 per year | neurocognitive assessment measured with Mullen Scales of Learning |
| Secondary | Whole Body Cholesterol Pool Size, Synthesis & Absorption Using Stable Isotope Testing | end of treatment, an average of 1 per year | administration of cholesterol and water labeled with stable isotope followed by measurement overtime in blood concentrations |
| Secondary | Plasma Marker of Sterol Metabolism | through study completion, an average of 2 per year | Blood cholesterol to 7-dehydrocholesterol ratio |
| Secondary | ADC | end of treatment, an average of 1 per year | Apparent diffusion coefficient measured by brain diffusion tensor imaging (DTI) |
| Secondary | MVA | through study completion, an average of 2 per year | urinary mevalonate excretion |
| Secondary | MRS Lipids | end of treatment, an average of 1 per year | Brain magnetic resonance spectroscopy |
| Secondary | FA | end of treatment, an average of 1 per year | Fractional anisotropy as measured by brain diffusion tensor imaging (DTI) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Development Quotient (DQ) | through study completion, an average of 2 per year | No funding | ||
| SECONDARY | Whole Body Cholesterol Pool Size, Synthesis & Absorption Using Stable Isotope Testing | end of treatment, an average of 1 per year | Analyses were not completed and will never be completed due to insufficient funding | ||
| SECONDARY | Plasma Marker of Sterol Metabolism | through study completion, an average of 2 per year | Analyses were not completed and will never be completed due to insufficient funding | ||
| SECONDARY | ADC | end of treatment, an average of 1 per year | Analyses were not completed and will never be completed due to insufficient funding | ||
| SECONDARY | MVA | through study completion, an average of 2 per year | Analyses were not completed and will never be completed due to insufficient funding | ||
| SECONDARY | MRS Lipids | end of treatment, an average of 1 per year | Analyses were not completed and will never be completed due to insufficient funding | ||
| SECONDARY | FA | end of treatment, an average of 1 per year | Analyses were not completed and will never be completed due to insufficient funding |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo - Lactose | 0 | |
| Overall Study | STARTED | Simvastatin | 0 | |
| Overall Study | COMPLETED | Placebo - Lactose | 0 | |
| Overall Study | COMPLETED | Simvastatin | 0 | |
| Overall Study | NOT COMPLETED | Placebo - Lactose | 0 | |
| Overall Study | NOT COMPLETED | Simvastatin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Lactose | ||
| Total, all-cause mortality | Simvastatin | ||
| Total, other adverse events | Placebo - Lactose | 0 | 1 |
| Total, other adverse events | Simvastatin | 0 | 1 |
| Total, serious adverse events | Placebo - Lactose | 0 | 1 |
| Total, serious adverse events | Simvastatin | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL073980 | Dietary Cholesterol and Defects in Cholesterol Synthesis | STEINER, ROBERT DAVID | MARSHFIELD CLINIC RESEARCH FOUNDATION | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Simvastatin vs Placebo - Lactose: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01434745
GET https://conductscience.org/api/trials/v1/NCT01434745/registered