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Dietary Cholesterol for Smith-Lemli-Opitz Syndrome

Phase 2

Waitlist Available

Research Sponsored by National Center for Research Resources (NCRR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Smith-Lemli-Opitz syndrom

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will study the effects of dietary cholesterol on patients with Smith-Lemli-Opitz syndrome, a disorder that affects cholesterol metabolism.

Who is the study for?

This trial is for individuals with Smith-Lemli-Opitz syndrome, a genetic condition that can cause physical abnormalities like cleft palate and wide-set eyes. Participants must have this specific syndrome to join the study.Check my eligibility

What is being tested?

The study is looking at how dietary cholesterol affects people with Smith-Lemli-Opitz syndrome. It will measure cholesterol absorption, plasma sterol composition, cholesterol synthesis and turnover, fecal bile acid excretion, and incorporation of deuterated water into various compounds.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication or invasive procedures, side effects are expected to be minimal. However, any potential digestive changes due to altered diet will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)Lead Sponsor

537 Previous Clinical Trials

317,011 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

6,846,024 Total Patients Enrolled

2 Trials studying Smith-Lemli-Opitz Syndrome

22 Patients Enrolled for Smith-Lemli-Opitz Syndrome

William ConnorStudy ChairOregon Health and Science University

2 Previous Clinical Trials

105 Total Patients Enrolled

Media Library

Dietary Cholesterol (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00004347 — Phase 2

Smith-Lemli-Opitz Syndrome Research Study Groups:

Smith-Lemli-Opitz Syndrome Clinical Trial 2023: Dietary Cholesterol Highlights & Side Effects. Trial Name: NCT00004347 — Phase 2

Dietary Cholesterol (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004347 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for participants in this trial?

"According to the records on clinicaltrials.gov, this medical trial is not currently enrolling participants; it was initially posted in November 1995 and last modified in June 2005. Although this investigation isn't presently seeking individuals for involvement, there are 1408 other studies that have open enrolment at present."

Answered by AI

What are the criteria for enrolling in this research project?

"This trial is recruiting 5 participants diagnosed with Smith-Lemli-Opitz syndrome, aged 0 to 0. In addition to this diagnosis, additional eligibility criteria must be met in order for patients to qualify."

Answered by AI

Could you please elucidate the safety of this treatment for patients?

"This treatment's safety is rated as a 2 out of 3 due to the fact that it has reached Phase 2 in clinical trials, thus indicating some evidence for its safety but no proof yet regarding efficacy."

Answered by AI

Are participants of this research endeavor restricted by age?

"This particular clinical trial is limited to participants between the ages of 0 and 18. Clinicialtrials.gov has a total of 395 trials available for minors, while those over 65 can choose from 991 studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome

1995. "Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00004347.

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