Autism Spectrum DisorderNCT02879110
A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder
A study testing Sulforaphane in people with Autism Spectrum Disorder, run by Central South University at 2 sites in China.
Trial summary
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 3 to 15 years.
- Meet DSM-V diagnostic criteria for autism spectrum disorder, and been checked with Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS).
Who cannot join
- With severe physical disease (i.e. congenital heart disease, thyroid disease, diseases with severe abnormality of liver or kidney function, diseases with abnormality vision or hearing et al.)
- With severe central nervous system disease (i.e. epilepsy et al).
- With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.)
Trial locations and contacts
2 sites in 1 country.
China2 sites
The second Xiangya hospital of central south university
Changsha, Hunan, 410001
Guangzhou Huiai Hospital
Guangzhou, Guangdong, 510000
About this study
Official title: A 12-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Related Mechanism of Sulforaphane in Treatment of Autism Spectrum Disorder
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. Biological samples also will be collected, and stored to research related mechanisms.
Read the detailed description
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. The investigators hypothesize that (1) sulforaphane is superior to placebo in the treatment of clinical symptoms in patients with ASD, measured by the Social Responsiveness Scale, Aberrant Behavior Checklist, Repetitive Behavior Scale - Revised and Ohio State University Autism Clinical Global Impression; (2) sulforaphane is superior to placebo in the treatment of other behavioral problems and adaptive behaviors patients with ASD, measured by Achenbach's Child Behavior Checklist and Adaptive Behavior Assessment System, Second Edition; and (3) Biological samples will be collected, and stored so that the hypothesis sulforaphane may alter oxidative stress indexes or inflammatory biomarkers, and influence histone deacetylase inhibitor mechanism or inflammatory mechanism et al that may be significantly correlated with clinical improvement.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Sulforaphane, Placebo
- Keywords
- Sulforaphane, clinic trial, Autism Spectrum Disorder, Efficacy, Safety, Mechanism
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDietary supplement
Also called 85313323
Sulforaphane (SFN) is a compound within the isothiocyanate group of organosulfur compounds. It is obtained from cruciferous vegetables such as broccoli, Brussels sprouts or cabbages.
PlaceboOther
Also called Starch tablet
Placebo tablet is composed of starch.
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphane group | Experimental | The patients will take sulforaphane for 12 weeks. Receives: Dietary Supplement: Sulforaphane |
| Placebo group | Placebo comparator | The patients will take placebo for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of social impairments of children with autism spectrum disorder
Social impairments are measured by Social Responsiveness Scale
Measured: At baseline, 4 week, 8 week and 12 week/endpoint
Secondary outcomes (18)
The change of rigid interests and behaviors of children with autism spectrum disorder
Rigid interests and behaviors are measured by Repetitive Behavior Scale - Revised
Measured: At baseline, 4 week, 8 week and 12 week/endpoint
The change of clinical symptoms of children with autism spectrum
Clinical symptoms are measured by Aberrant Behavior Checklist
Measured: At baseline, 4 week, 8 week and 12 week/endpoint
The change of other behavioral problems of children with autism spectrum
Other behavioral problems are measured by Achenbach's Child Behavior Checklist
Measured: At baseline, 4 week, 8 week and 12 week/endpoint
The change of adaptive behaviors of children with autism spectrum
Adaptive behaviors are measured by Adaptive Behavior Assessment System, Second Edition
Measured: At baseline, 4 week, 8 week and 12 week/endpoint
The change of clinical general impression of children with autism spectrum
Clinical general impression is measured by Ohio State University Autism Clinical Global Impression
Measured: At baseline, 4 week, 8 week and 12 week/endpoint
The change of heart rate as measured by stopwatch
Measured: At baseline and 12 week/endpoint
The change of weight as measured by weighing-machine
Measured: At baseline and 12 week/endpoint
The change of height as measured by Height measurement tools
Measured: At baseline and 12 week/endpoint
The change of blood routine test as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of fasting blood-glucose as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of blood lipid as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of liver function as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of kidney function as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of thyroid function as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of HBV test as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of helicobacter pylori test as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
The change of urine routine test as tested by clinical laboratory
Measured: At baseline and 12 week/endpoint
Number of participants with treatment-related adverse events as assessed by Systematic Assessment for Treatment Emergent Effects
Measured: At 4 week, 8 week and 12 week/endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Davis family funding, University of California, University of Illinois Chicago
- Responsible party
- Principal investigator, Jian-Jun Ou, Central South University
- Investigators
- Jingping Zhao, M.D., Ph. D., Study chair, Central South UniversityJianjun Ou, M.D., Ph. D., Study director, Central South UniversityHua Jin, M.D., Ph. D., Study director, Department of Psychiatry, University of CaliforniaFengyu Zhang, Ph.D., Principal investigator, Global Clinical and Translational Research InstituteDaomeng Cheng, M.D., Principal investigator, Guangzhou Huiai HospitalRenrong Wu, M.D.,Ph.D, Principal investigator, Central South UniversityJohn M Davis, M.D.,Ph.D, Study director, Department of Psychiatry, University of Illinoisat at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879110
- Sponsor's protocol ID
- ASD201512
- Status last verified
- Jul 2019
- First submitted
- 15 Aug 2016
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Foley AG, Cassidy AW, Regan CM. Pentyl-4-yn-VPA, a histone deacetylase inhibitor, ameliorates deficits in social behavior and cognition in a rodent model of autism spectrum disorders. Eur J Pharmacol. 2014 Mar 15;727:80-6. doi: 10.1016/j.ejphar.2014.01.050. Epub 2014 Jan 31.
PubMed 24486700Houghton CA, Fassett RG, Coombes JS. Sulforaphane: translational research from laboratory bench to clinic. Nutr Rev. 2013 Nov;71(11):709-26. doi: 10.1111/nure.12060. Epub 2013 Oct 22.
PubMed 24147970Moldrich RX, Leanage G, She D, Dolan-Evans E, Nelson M, Reza N, Reutens DC. Inhibition of histone deacetylase in utero causes sociability deficits in postnatal mice. Behav Brain Res. 2013 Nov 15;257:253-64. doi: 10.1016/j.bbr.2013.09.049. Epub 2013 Oct 5.
PubMed 24103642Foley AG, Gannon S, Rombach-Mullan N, Prendergast A, Barry C, Cassidy AW, Regan CM. Class I histone deacetylase inhibition ameliorates social cognition and cell adhesion molecule plasticity deficits in a rodent model of autism spectrum disorder. Neuropharmacology. 2012 Sep;63(4):750-60. doi: 10.1016/j.neuropharm.2012.05.042. Epub 2012 Jun 6.
PubMed 22683514Montes G, Halterman JS. Association of childhood autism spectrum disorders and loss of family income. Pediatrics. 2008 Apr;121(4):e821-6. doi: 10.1542/peds.2007-1594.
PubMed 18381511Montes G, Halterman JS. Child care problems and employment among families with preschool-aged children with autism in the United States. Pediatrics. 2008 Jul;122(1):e202-8. doi: 10.1542/peds.2007-3037.
PubMed 18595965Mugno D, Ruta L, D'Arrigo VG, Mazzone L. Impairment of quality of life in parents of children and adolescents with pervasive developmental disorder. Health Qual Life Outcomes. 2007 Apr 27;5:22. doi: 10.1186/1477-7525-5-22.
PubMed 17466072Myzak MC, Tong P, Dashwood WM, Dashwood RH, Ho E. Sulforaphane retards the growth of human PC-3 xenografts and inhibits HDAC activity in human subjects. Exp Biol Med (Maywood). 2007 Feb;232(2):227-34.
PubMed 17259330Ou JJ, Shi LJ, Xun GL, Chen C, Wu RR, Luo XR, Zhang FY, Zhao JP. Employment and financial burden of families with preschool children diagnosed with autism spectrum disorders in urban China: results from a descriptive study. BMC Psychiatry. 2015 Jan 22;15:3. doi: 10.1186/s12888-015-0382-4.
PubMed 25608486Rossignol DA, Frye RE. A review of research trends in physiological abnormalities in autism spectrum disorders: immune dysregulation, inflammation, oxidative stress, mitochondrial dysfunction and environmental toxicant exposures. Mol Psychiatry. 2012 Apr;17(4):389-401. doi: 10.1038/mp.2011.165. Epub 2011 Dec 6.
PubMed 22143005Schieve LA, Blumberg SJ, Rice C, Visser SN, Boyle C. The relationship between autism and parenting stress. Pediatrics. 2007 Feb;119 Suppl 1:S114-21. doi: 10.1542/peds.2006-2089Q.
PubMed 17272578Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.
PubMed 25313065
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Related Mechanism of Sulforaphane in Treatment of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02879110
- Acronym / sponsor ID
- ASD201512
- Conditions
- Autism Spectrum Disorder
- Keywords
- Sulforaphane, clinic trial, Autism Spectrum Disorder, Efficacy, Safety, Mechanism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Davis family funding, University of California, University of Illinois Chicago
- Study start
- Aug 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. Biological samples also will be collected, and stored to research related mechanisms.
Detailed description
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. The investigators hypothesize that (1) sulforaphane is superior to placebo in the treatment of clinical symptoms in patients with ASD, measured by the Social Responsiveness Scale, Aberrant Behavior Checklist, Repetitive Behavior Scale - Revised and Ohio State University Autism Clinical Global Impression; (2) sulforaphane is superior to placebo in the treatment of other behavioral problems and adaptive behaviors patients with ASD, measured by Achenbach's Child Behavior Checklist and Adaptive Behavior Assessment System, Second Edition; and (3) Biological samples will be collected, and stored so that the hypothesis sulforaphane may alter oxidative stress indexes or inflammatory biomarkers, and influence histone deacetylase inhibitor mechanism or inflammatory mechanism et al that may be significantly correlated with clinical improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane group | Experimental | Dietary Supplement: SulforaphaneThe patients will take sulforaphane for 12 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboThe patients will take placebo for 12 weeks. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 3 to 15 years.
- Meet DSM-V diagnostic criteria for autism spectrum disorder, and been checked with Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS).
Key exclusion criteria (3 listed)
- With severe physical disease (i.e. congenital heart disease, thyroid disease, diseases with severe abnormality of liver or kidney function, diseases with abnormality vision or hearing et al.)
- With severe central nervous system disease (i.e. epilepsy et al).
- With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulforaphaneAlso: 85313323Sulforaphane (SFN) is a compound within the isothiocyanate group of organosulfur compounds. It is obtained from cruciferous vegetables such as broccoli, Brussels sprouts or cabbages. | Dietary supplement | Sulforaphane group |
| PlaceboAlso: Starch tabletPlacebo tablet is composed of starch. | Other | Placebo group |
Primary outcome
The change of social impairments of children with autism spectrum disorder
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
Social impairments are measured by Social Responsiveness Scale
18 secondary outcomes
The change of rigid interests and behaviors of children with autism spectrum disorder
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
The change of clinical symptoms of children with autism spectrum
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
The change of other behavioral problems of children with autism spectrum
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
The change of adaptive behaviors of children with autism spectrum
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
The change of clinical general impression of children with autism spectrum
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
The change of heart rate as measured by stopwatch
Time frame: At baseline and 12 week/endpoint
The change of weight as measured by weighing-machine
Time frame: At baseline and 12 week/endpoint
The change of height as measured by Height measurement tools
Time frame: At baseline and 12 week/endpoint
The change of blood routine test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of fasting blood-glucose as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of blood lipid as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of liver function as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of kidney function as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of thyroid function as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of HBV test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of helicobacter pylori test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of urine routine test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
Number of participants with treatment-related adverse events as assessed by Systematic Assessment for Treatment Emergent Effects
Time frame: At 4 week, 8 week and 12 week/endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 24486700Foley AG, Cassidy AW, Regan CM. Pentyl-4-yn-VPA, a histone deacetylase inhibitor, ameliorates deficits in social behavior and cognition in a rodent model of autism spectrum disorders. Eur J Pharmacol. 2014 Mar 15;727:80-6. doi: 10.1016/j.ejphar.2014.01.050. Epub 2014 Jan 31.
- Background: PubMed 24147970Houghton CA, Fassett RG, Coombes JS. Sulforaphane: translational research from laboratory bench to clinic. Nutr Rev. 2013 Nov;71(11):709-26. doi: 10.1111/nure.12060. Epub 2013 Oct 22.
- Background: PubMed 24103642Moldrich RX, Leanage G, She D, Dolan-Evans E, Nelson M, Reza N, Reutens DC. Inhibition of histone deacetylase in utero causes sociability deficits in postnatal mice. Behav Brain Res. 2013 Nov 15;257:253-64. doi: 10.1016/j.bbr.2013.09.049. Epub 2013 Oct 5.
- Background: PubMed 22683514Foley AG, Gannon S, Rombach-Mullan N, Prendergast A, Barry C, Cassidy AW, Regan CM. Class I histone deacetylase inhibition ameliorates social cognition and cell adhesion molecule plasticity deficits in a rodent model of autism spectrum disorder. Neuropharmacology. 2012 Sep;63(4):750-60. doi: 10.1016/j.neuropharm.2012.05.042. Epub 2012 Jun 6.
- Background: PubMed 18381511Montes G, Halterman JS. Association of childhood autism spectrum disorders and loss of family income. Pediatrics. 2008 Apr;121(4):e821-6. doi: 10.1542/peds.2007-1594.
- Background: PubMed 18595965Montes G, Halterman JS. Child care problems and employment among families with preschool-aged children with autism in the United States. Pediatrics. 2008 Jul;122(1):e202-8. doi: 10.1542/peds.2007-3037.
- Background: PubMed 17466072Mugno D, Ruta L, D'Arrigo VG, Mazzone L. Impairment of quality of life in parents of children and adolescents with pervasive developmental disorder. Health Qual Life Outcomes. 2007 Apr 27;5:22. doi: 10.1186/1477-7525-5-22.
- Background: PubMed 17259330Myzak MC, Tong P, Dashwood WM, Dashwood RH, Ho E. Sulforaphane retards the growth of human PC-3 xenografts and inhibits HDAC activity in human subjects. Exp Biol Med (Maywood). 2007 Feb;232(2):227-34.
- Background: PubMed 25608486Ou JJ, Shi LJ, Xun GL, Chen C, Wu RR, Luo XR, Zhang FY, Zhao JP. Employment and financial burden of families with preschool children diagnosed with autism spectrum disorders in urban China: results from a descriptive study. BMC Psychiatry. 2015 Jan 22;15:3. doi: 10.1186/s12888-015-0382-4.
- Background: PubMed 22143005Rossignol DA, Frye RE. A review of research trends in physiological abnormalities in autism spectrum disorders: immune dysregulation, inflammation, oxidative stress, mitochondrial dysfunction and environmental toxicant exposures. Mol Psychiatry. 2012 Apr;17(4):389-401. doi: 10.1038/mp.2011.165. Epub 2011 Dec 6.
- Background: PubMed 17272578Schieve LA, Blumberg SJ, Rice C, Visser SN, Boyle C. The relationship between autism and parenting stress. Pediatrics. 2007 Feb;119 Suppl 1:S114-21. doi: 10.1542/peds.2006-2089Q.
- Background: PubMed 25313065Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingping Zhao, M.D., Ph. D. study chair
Central South University
Jianjun Ou, M.D., Ph. D. study director
Central South University
Hua Jin, M.D., Ph. D. study director
Department of Psychiatry, University of California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulforaphane in people with Autism Spectrum Disorder, run by Central South University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of social impairments of children with autism spectrum disorder (time frame: At baseline, 4 week, 8 week and 12 week/endpoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879110, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019; AzTrials last refreshed its copy on 3 Nov 2026.