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SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation

NCT01434745 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-10-01

Study results available
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Summary

The purpose of this study is to determine if simvastatin improves development and behavior in patients with Smith Lemli-Opitz syndrome (SLOS) receiving dietary cholesterol supplementation.

Conditions

  • Smith-Lemli-Opitz Syndrome

Interventions

DRUG

Simvastatin

Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day

DIETARY_SUPPLEMENT

Lactose

Lactose will be administered in a capsule formula.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jean-Baptiste Roullet, PhD · Washington State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01434745 on ClinicalTrials.gov