Trial · NCT01474993
Sulforaphane-rich Broccoli Sprout Extract for Autism
NCT01474993, Phase 2, Completed, Andrew Zimmerman; results first posted 2014-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sulforaphane-rich Broccoli Sprout Extract for Autism. Trials, record NCT01474993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01474993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sulforaphane-rich Broccoli Sprout Extract for Autism
- NCT number
- NCT01474993
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Andrew Zimmerman
- Conditions
- Autism
- Interventions
- Sulforaphane-rich Broccoli Sprout Extract, Placebo
- First posted
- 2011-11-18
- Last updated
- 2018-09-12
- Results first posted
- 2014-11-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks and 22 weeks | The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated on the scoring sheet on a scale from "0" to "3", where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome. For the purposes of this study, SRS scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average SRS scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively. |
| Secondary | Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks, 22 weeks | The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of "0" for particular behavior is not a problem at all, "1" indicates that the behavior is a problem but slight in degree, "2" indicates that the problem is moderately serious, and "3" indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome. For the purposes of this study, ABC scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average ABC scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively. |
| Secondary | Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks, 22 weeks | OACIS-S is a 10 domain scale that requires the clinician to rate the severity of the patient's autism symptoms at the time of assessment. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests. Each domain is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. |
| Secondary | Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks, 22 weeks | The Ohio Autism Clinical Impressions Improvement Scale (OACIS-I) is a 10 domain scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests. Each domain is rated on a scale of 1 to 7, where "1" is very much improved; "2" is much improved; "3" is minimally improved; "4" is no change; "5" is minimally worse; "6" is much worse; or "7" is very much worse. |
| Secondary | Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | |
| Secondary | Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | |
| Secondary | Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | |
| Secondary | Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | |
| Secondary | White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | |
| Secondary | Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks and 22 weeks | units on a scale | MEAN | |
| SECONDARY | Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks, 22 weeks | units on a scale | MEAN | |
| SECONDARY | Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks, 22 weeks | units on a scale | MEAN | |
| SECONDARY | Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 10 weeks, 18 weeks, 22 weeks | units on a scale | MEAN | |
| SECONDARY | Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | U/L | MEAN | |
| SECONDARY | Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | mg/dL | MEAN | |
| SECONDARY | Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | uIU/mL | MEAN | |
| SECONDARY | Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | *10^6 cells/µL | MEAN | |
| SECONDARY | White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | *10^3 cells/µL | MEAN | |
| SECONDARY | Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks | *10^3 cells/µL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group222
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Placebo | Change from screening/baseline at 4 weeks | -7.79 | Standard Deviation 3.09 | units on a scale |
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Sulforaphane-rich Broccoli Sprout Extract | Change from screening/baseline at 4 weeks | -14.76 | Standard Deviation 3.79 | units on a scale |
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Placebo | Change from screening/baseline at 10 weeks | -1.38 | Standard Deviation 3.72 | units on a scale |
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Sulforaphane-rich Broccoli Sprout Extract | Change from screening/baseline at 10 weeks | -14.48 | Standard Deviation 5.72 | units on a scale |
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Placebo | Change from screening/baseline at 18 weeks | -2.0 | Standard Deviation 3.46 | units on a scale |
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Sulforaphane-rich Broccoli Sprout Extract | Change from screening/baseline at 18 weeks | -20.40 | Standard Deviation 4.54 | units on a scale |
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Placebo | Change from screening/baseline at 22 weeks | -6.67 | Standard Deviation 3.82 | units on a scale |
| Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Sulforaphane-rich Broccoli Sprout Extract | Change from screening/baseline at 22 weeks | -7.03 | Standard Deviation 4.20 | units on a scale |
| Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Placebo | Change from screening/baseline at 4 weeks | 0.77 | Standard Deviation 1.84 | units on a scale |
| Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | Sulforaphane-rich Broccoli Sprout Extract | Change from screening/baseline at 4 weeks | -12.69 | Standard Deviation 4.17 | units on a scale |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | STARTED | Sulforaphane-rich Broccoli Sprout Extract | 29 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | COMPLETED | Sulforaphane-rich Broccoli Sprout Extract | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Sulforaphane-rich Broccoli Sprout Extract | 3 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 14 | |
| other | Vomiting | Gastrointestinal disorders | Sulforaphane-rich Broccoli Sprout Extract | 5 | 26 | |
| other | Increased aggressions | Psychiatric disorders | Placebo | 2 | 14 | |
| other | Increased aggressions | Psychiatric disorders | Sulforaphane-rich Broccoli Sprout Extract | 4 | 26 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | Sulforaphane-rich Broccoli Sprout Extract | 4 | 26 | |
| other | Increased Flatulence | Gastrointestinal disorders | Placebo | 2 | 14 | |
| other | Increased Flatulence | Gastrointestinal disorders | Sulforaphane-rich Broccoli Sprout Extract | 4 | 26 | |
| other | Increased irritability | Psychiatric disorders | Placebo | 0 | 14 | |
| other | Increased irritability | Psychiatric disorders | Sulforaphane-rich Broccoli Sprout Extract | 3 | 26 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Sulforaphane-rich Broccoli Sprout Extract | ||
| Total, other adverse events | Placebo | 4 | 14 |
| Total, other adverse events | Sulforaphane-rich Broccoli Sprout Extract | 5 | 26 |
| Total, serious adverse events | Placebo | 0 | 14 |
| Total, serious adverse events | Sulforaphane-rich Broccoli Sprout Extract | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sulforaphane-rich Broccoli Sprout Extract vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01474993
GET https://conductscience.org/api/trials/v1/NCT01474993/results?page=2