Sulforaphane (SF) will be administered once a day orally in an approximate dose of 1 µmol/lb (2.2 kg µmol/kg) body weight. Each SF tablet will contain 125 mg broccoli seed powder (equivalent to ~ 15 µmol SF). The total dose per day will depend on participants' body weight:
30-50 lb: 3 tablets (45 µmol/day) 50-70 lb: 4 tablets (60 µmol/day) 70-90 lb: 6 tablets (90 µmol/day) 90-110 lb: 7 tablets (105 µmol/day) 110-130 lb: 8 tablets (120 µmol/day)
For pilot study, all participants (n=10) will receive SF for 14 days. For main clinical trial, 25 participants will randomly receive SF for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo to sulforaphane arm will take place, and all participants will receive SF from 15-30 weeks.

Placebo tablets identical in size and similar in appearance to the active tablets will be used. Number of placebo tablets will be equivalent to the active tablets depending on participants' body weight.
For the main clinical trial, 25 participants will be randomly allocated to receive placebo for 15 weeks (phase 1). During phase 2, a single-arm crossover from placebo arm to sulforaphane arm will take place, and all participants will receive sulforaphane from 15-30 weeks.

Autism Spectrum Disorder

Sulforaphane

Placebo

University of Massachusetts Medical School

Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD)

Response rate described as proportion of study participants who have much improved or very much improved on the OACIS-I subscale

Andrew Zimmerman

Clinical Professor of Pediatrics and Neurology

University of Massachusetts, Worcester

Congressionally Directed Medical Research Programs

Johns Hopkins University

sulforaphane-rich Broccoli Sprout Extract.

15 participants were randomized to placebo.

29 subjects were randomized to receive sulforaphane.

Sulforaphane-rich Broccoli Sprout Extract

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

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.

Aberrant Behavior Checklist total score

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.

Social Responsiveness Scale total score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about the overall level of autism. The question 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.

OACIS-S general level of autism score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about social interaction impairment. The question 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.

OACIS-S social interaction score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires aberrant behaviors (such as aggressions etc.). The question 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.

OACIS-S aberrant behavior score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about repetitive/ritualistic behaviors. The question 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.

OACIS-S repetitive behavior score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about impairment of verbal communication skills. The question 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.

OACIS-S verbal communication score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about impairment of non-verbal communication skills. The question 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.

OACIS-S nonverbal communication score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about severity of hyperactivity and inattentiveness. The question 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.

OACIS-S hyperactivity/inattention score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about severity of anxiety. The question 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.

OACIS-S anxiety score

This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about severity of sensory sensitivities. The question 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.

OACIS-S sensory sensitivity score

This question on Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about restricted and narrow interests of the patient. The question 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.

OACIS-S restricted interests score

Hematology: Red Blood Cell (RBC) counts

Hematology: White Blood Cell (WBC) counts

Hematology: platelet counts

Blood chemistry: serum creatinine

Blood Chemistry: Serum glutamic oxaloacetic transaminase (SGOT)

Blood Chemistry: Serum glutamic pyruvic transaminase (SGPT)

Blood chemistry: Thyroid Stimulating Hormone (TSH)

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.

Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.

Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.

Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 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.

Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 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.

Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 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.

Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks

Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks

Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks

Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks

Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks

White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks

Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks

*Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.

Sulforaphane-rich Broccoli Sprout Extract.

Interventional

Change From Screening and Baseline in Urinary Isoprostane F2α-VI Levels at 24 Hours After First Dose, at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks

Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.

Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks

15 participants were randomized to placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose).One participant in placebo group dropped out before starting study drug. 14 participants completed the study.

29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study.
Sulforaphane-rich Broccoli Sprout Extract: The medication was supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane depended on subject's body weight:
Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)
Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)
Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)

Overall Study

Andrew Zimmerman, M.D.

15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed.

29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed.

Autism

30 subjects will be randomly selected to receive sulforaphane-rich Broccoli Sprout Extract. The medication will be supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane will depend on subject's body weight:
Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)
Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)
Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)

15 subjects will be randomly selected to receive inactive placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose)

Lurie Center for Autism, MassGeneral Hospital for Children

Sulforaphane-rich Broccoli Sprout Extract for Autism

Pediatric Neurologist

Subjects who undergo respiratory infection (acute bronchitis) without COPD or other respiratory illness

isothiocyanate/palavik

Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD)

Sulforaphane-rich Broccoli Sprout Extract for Autism

Granzymes and Perforin at the Onset of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

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