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Cholesterol in ASD: Characterization and Treatment

NCT00965068 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-07-05

No results posted yet for this 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 blood draws and cheek swabs.

Conditions

  • Autism
  • Asperger Disorder
  • PDD-NOS

Interventions

OTHER

Cholesterol

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Forbes D Porter, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-28
Completion
2013-11-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00965068 on ClinicalTrials.gov