Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 13 - 30 |
| Updated: | 12/15/2018 |
| Start Date: | February 2016 |
| End Date: | January 2022 |
| Contact: | Edward S Stenroos |
| Email: | stenroos@rutgers.edu |
| Phone: | 732 235 5490 |
Sulforaphane in Autism: A Treatment Trial to Confirm Phenotypic Improvement With Sulforaphane Treatment in a New Jersey (NJ) Population of Individuals With Autism
This study is a double blind treatment trial that will test if sulforaphane improves core
symptoms in autism. The investigators expect to see clinical improvement in some of these
areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators
will be using a preparation that gives specific and reproducible amounts. The investigators
will also test specific chemicals and genes needed for sulforaphane usage to try to
understand differences in response.
symptoms in autism. The investigators expect to see clinical improvement in some of these
areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators
will be using a preparation that gives specific and reproducible amounts. The investigators
will also test specific chemicals and genes needed for sulforaphane usage to try to
understand differences in response.
This study is a double blind randomized treatment trial that will test if sulforaphane
improves core symptoms in autism. It is designed to try to replicate a previous trial
(ClinicalTrials.gov Identifier NCT01474993) which reported that the isothiocyanate,
sulforaphane treatment led to improvement by multiple metrics. Significant improvement was
seen in behavior as measured by the Aberrant Behavioral Checklist (ABC) and by the Social
Responsiveness Scale (SRS). In addition a significantly greater number of participants
receiving sulforaphane had improvement in social interaction, abnormal behavior, and verbal
communication as per the Clinical Global Impression (CGI). In addition The investigators will
attempt to account for some variability in response to sulforaphane treatment by testing
alleles of genes that are relevant in sulforaphane metabolism. The investigators will also
measure glutathione levels, which are also important in sulforaphane metabolism and are in
part regulated by sulforaphane..
Sulforaphane is the most potent naturally occurring inducer of mammalian cytoprotective
enzymes known. Therapeutic potential is based at least in part on their ability to
up-regulate genes responsible for alleviation of oxidative stress and to regulate both the
immune system and the inflammatory response
40 Males with autistic disorder will be randomly selected to receive either sulforaphane or
placebo. Seven visits are required by the subjects including enrollment ,screening, baseline,
weeks 4, 10 and 18 and a follow up visit at seek 22.
improves core symptoms in autism. It is designed to try to replicate a previous trial
(ClinicalTrials.gov Identifier NCT01474993) which reported that the isothiocyanate,
sulforaphane treatment led to improvement by multiple metrics. Significant improvement was
seen in behavior as measured by the Aberrant Behavioral Checklist (ABC) and by the Social
Responsiveness Scale (SRS). In addition a significantly greater number of participants
receiving sulforaphane had improvement in social interaction, abnormal behavior, and verbal
communication as per the Clinical Global Impression (CGI). In addition The investigators will
attempt to account for some variability in response to sulforaphane treatment by testing
alleles of genes that are relevant in sulforaphane metabolism. The investigators will also
measure glutathione levels, which are also important in sulforaphane metabolism and are in
part regulated by sulforaphane..
Sulforaphane is the most potent naturally occurring inducer of mammalian cytoprotective
enzymes known. Therapeutic potential is based at least in part on their ability to
up-regulate genes responsible for alleviation of oxidative stress and to regulate both the
immune system and the inflammatory response
40 Males with autistic disorder will be randomly selected to receive either sulforaphane or
placebo. Seven visits are required by the subjects including enrollment ,screening, baseline,
weeks 4, 10 and 18 and a follow up visit at seek 22.
Inclusion Criteria:
- Autistic disorder diagnosis.
- Age between 13-30 years.
- Male gender.
Exclusion Criteria:
- Absence of a parent or legal guardian and consent,
- Those that can not or will not complete all visits and adherence to study regimen.
- Seizure within 2 years of screening,
- Impaired renal function (serum creatinine> 1.2 mg/dl).
- Impaired hepatic function (> 2x upper limit of normal).
- Impaired thyroid function (TSH outside normal limits).
- Current infection or treatment with antibiotics.
- Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major
surgery within 3 months prior to enrollment.
- Less than 13 years or more than 30 years of age.
- Female gender.
- A diagnosis of autism spectrum disorder other than autistic disorder, for example,
Asperger, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.
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