NCT00965068

Cholesterol in ASD: Characterization and Treatment

Completed Phase 1, PHASE2 Last updated 5 July 2018

What this trial tests

Phase 1, PHASE2 trial testing Cholesterol in Autism in 44 participants. Completed in 14 November 2013.

Timeline

28 July 2009

14 November 2013

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	treatment
Enrollment	44
Start date	28 July 2009
Estimated completion	14 November 2013
Sites	1 location across United States

Drugs / interventions tested

• Cholesterol (CHOLESTEROL) — full drug profile →

Conditions studied

• Autism — all drugs for Autism →
• Asperger Disorder — all drugs for Asperger Disorder →
• PDD-NOS — all drugs for PDD-NOS →

Sponsor

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

Who can join

Adults 4 to 12, any sex, with Autism or Asperger Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Testing genetic modifiers of behavior and response to atomoxetine in autism spectrum disorder with ADHD.
   Barrie ES, Pinsonneault JK, Sadee W, Hollway JA, et al · · 2018 · cited 12× · PMID 30197492 · DOI 10.1007/s10882-018-9590-4