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NCT00965068 · ClinicalTrials.gov registry record · Phase 1
Cholesterol in ASD: Characterization and Treatment
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00965068 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 44 participants.
The verdict
NCT00965068, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Background: \- Autism spectrum disorders (ASD) are developmental disabilities characterized by impaired social interaction and repetitive and/or stereotypical behaviors. Research studies suggest that some individuals with ASD have very low blood cholesterol levels. This low cholesterol level and other abnormal sterol levels may be important markers for subtypes of ASD. Providing additional cholesterol to the diets of children with ASD may help improve behavior. \- These findings will guide the medical community in identifying individuals who should be tested for sterol disorders. This study will also help researchers learn whether adding extra cholesterol to the diet will improve behavioral and other autism spectrum characteristics seen in individuals with ASD and low cholesterol. Objectives: * To determine cholesterol levels in children with autism spectrum disorders. * To compare behavioral and other characteristics among children who have autism spectrum disorders and high, low, or normal cholesterol levels. * To determine whether adding cholesterol to the diet will improve behavioral and other characteristics in individuals with ASD and low cholesterol. Eligibility: \- Children between the ages of 4 and 12 who have been diagnosed with an autism spectrum disorder. Design: * Initial screening study will involve a collection of blood samples (for study purposes and cholesterol testing). * Children who have low cholesterol levels will take part in a study in which they will receive either cholesterol supplementation or a placebo, and will have detailed physical and psychological examinations to measure possible improvement in behavioral or other characteristics. * Children who have high or normal cholesterol levels will have further blood samples taken, and will undergo an additional set of examinations for comparison purposes. * Researchers may request blood or DNA samples from other family members (parents or siblings), which will be collected through blo
Interventions
- OTHER Cholesterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2009-07-28 |
| Est. Completion | 2013-11-14 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00965068
The ClinicalTrials.gov registry entry for NCT00965068 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cholesterol is the first listed.
NCT00965068 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00965068 about?
NCT00965068 is a clinical study titled "Cholesterol in ASD: Characterization and Treatment". Background: \- Autism spectrum disorders (ASD) are developmental disabilities characterized by impaired social interaction and repetitive and/or stereotypical behaviors. Research studies suggest that some individuals with ASD have very low blood cholesterol levels. This low cholesterol level and ot...
What is the current status of trial NCT00965068?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2009-07-28. Estimated completion is 2013-11-14.
What interventions are being tested in trial NCT00965068?
The interventions under investigation include: Cholesterol (OTHER).
Who is sponsoring clinical trial NCT00965068?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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