Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01260961|
Recruitment Status : Active, not recruiting
First Posted : December 15, 2010
Last Update Posted : November 29, 2016
Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3 fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of autism.
We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with no drug in it) on several aspects of autism in children and adolescents, in a 12-week clinical study with children or adolescents in the age group of 5-17 with a diagnosis of Autism Spectrum Disorder. Additionally this trial will study genes related to the therapeutic agent, DHA, and biomarkers related to DHA in the urine.
|Condition or disease||Intervention/treatment||Phase|
|Autism||Dietary Supplement: Placebo Dietary Supplement: Docosahexanoic Acid||Not Applicable|
Growing evidence supports oxidative stress may contribute to autism. Docosa Hexanoic Acid(DHA)is a normal substance that is present in large amounts in the brain and can be used by the body to produce natural antioxidants. Our hope is that supplementing DHA in individuals with autism may improve some aspects of their functioning. Specifically our aims are:
Aim 1. To assess the effect of DHA vs. placebo treatment on the global severity of child and adolescent autistic disorder, via a 12-week double blind placebo-controlled parallel study. Global severity will be assessed by the Autism Diagnostic Observation Schedule-Generic (ADOS-G) and additionally in younger children by the Vineland Adaptive Behavior Scale.
Aim 2. To assess the effect of DHA vs. placebo treatment on behavioral symptoms and functional ability in children with autism. Assessment will be by the Aberrant Behavior Checklist (ABC)-Community Version11.
Aim 3. To develop an improved protocol and study design based upon these studies for future large scale studies of DHA in the autistic population.
Aim 4. Monitor the effects of therapy on the isoprostane biomarker. Aim 5: Develop additional biomarkers that correlate with autism and with therapy. We will extend the analyses to neuroprostanes and resolvins. We will measure: (i) Urinary excretion of the isoprostane metabolites, 2,3 Dinor-5,6 dihydro-PGF2t and iPF4α-VI. (ii) DHA derived resolvins D2, D4, D5 and D6 and neuroprotectin.
Aim 6: Confirm our preliminary results by correlating increased isoprostane excretion with GSTM1*0 copy number in individuals with autism.
Aim 7: In the same way, correlate GSTM1*0 copy number with response to therapy assessed by diminution of isoprostane excretion during therapy.
Aim 8: Study additional biomarkers developed through Hypothesis #2 for correlation with GSTM1*0 copy number and response to therapy to identify additional gene-biomarker correlations.
Aim 9: Study additional polymorphisms of genes related to DHA metabolism, for association with autism, gene-biomarker correlations, and correlation with response to therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||December 2017|
|Active Comparator: Docosa Hexanoic Acid||
Dietary Supplement: Docosahexanoic Acid
The volunteers will start on the 200 mg daily of the DHA capsule and will not increase their dose during the study.
Other Name: DHA
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
The volunteers will start on the 200 mg daily of the placebo and will not increase their dose during the study.
- Amelioration of phenotypic features of autism [ Time Frame: three years ]Amelioration of phenotypic features of autism as measured by a significant decrease from the baseline, in global severity of autism score and Aberrant Behavior Checklist scores
- oxidative stress biomarkers [ Time Frame: Three years ]
We will be measuring isoprostane 8-iso-PGF2a.
The measurements will be in ng mg Creatinine and we expect a significant decrease in levels from the baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260961
|United States, New Jersey|
|Piscataway, New Jersey, United States, 08854|
|Principal Investigator:||Sherie Novotny, MD||Rutgers-RWJMS|