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Sulforaphane-rich Broccoli Sprout Extract for Autism

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Andrew Zimmerman, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01474993
First received: November 8, 2011
Last updated: November 19, 2014
Last verified: November 2014
Results First Received: November 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Autism
Interventions: Drug: Sulforaphane-rich Broccoli Sprout Extract
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Forty-four study participants were initially enrolled in the study from January 2011 to July 2013 at Lurie Center for Autism.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo 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.
Sulforaphane-rich Broccoli Sprout Extract

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:

  1. Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)
  2. Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)
  3. Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)

Participant Flow:   Overall Study
    Placebo     Sulforaphane-rich Broccoli Sprout Extract  
STARTED     15     29  
COMPLETED     14     26  
NOT COMPLETED     1     3  
Lost to Follow-up                 1                 2  
Adverse Event                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 15 participants were randomized to placebo.
Sulforaphane-rich Broccoli Sprout Extract 29 subjects were randomized to receive sulforaphane.
Total Total of all reporting groups

Baseline Measures
    Placebo     Sulforaphane-rich Broccoli Sprout Extract     Total  
Number of Participants  
[units: participants]
  15     29     44  
Age  
[units: years]
Mean ± Standard Deviation
  16.6  ± 3.5     17.9  ± 3.9     17.4  ± 3.9  
Gender  
[units: participants]
     
Female     0     0     0  
Male     15     29     44  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     2     2  
White     13     26     39  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     15     29     44  
Aberrant Behavior Checklist total score [1]
[units: units on a scale]
Mean ± Standard Deviation
  60  ± 23.2     63.6  ± 25.3     62.3  ± 24.4  
Social Responsiveness Scale total score [2]
[units: units on a scale]
Mean ± Standard Deviation
  120.1  ± 16.6     122.2  ± 24.1     121.5  ± 21.6  
OACIS-S general level of autism score [3]
[units: units on a scale]
Mean ± Standard Deviation
  4.53  ± 0.74     4.38  ± 0.56     4.43  ± 0.62  
OACIS-S social interaction score [4]
[units: units on a scale]
Mean ± Standard Deviation
  4.80  ± 1.01     4.51  ± 0.69     4.61  ± 0.81  
OACIS-S aberrant behavior score [5]
[units: units on a scale]
Mean ± Standard Deviation
  4.20  ± 1.37     4.21  ± 0.86     4.20  ± 1.05  
OACIS-S repetitive behavior score [6]
[units: units on a scale]
Mean ± Standard Deviation
  4.13  ± 0.83     4.14  ± 0.74     4.13  ± 0.77  
OACIS-S verbal communication score [7]
[units: units on a scale]
Mean ± Standard Deviation
  4.53  ± 1.36     4.45  ± 0.95     4.48  ± 1.09  
OACIS-S nonverbal communication score [8]
[units: units on a scale]
Mean ± Standard Deviation
  4.27  ± 0.96     4.10  ± 0.72     4.16  ± 0.81  
OACIS-S hyperactivity/inattention score [9]
[units: units on a scale]
Mean ± Standard Deviation
  4.40  ± 0.91     4.10  ± 0.90     4.20  ± 0.90  
OACIS-S anxiety score [10]
[units: units on a scale]
Mean ± Standard Deviation
  4.33  ± 1.23     4.17  ± 0.71     4.23  ± 0.91  
OACIS-S sensory sensitivity score [11]
[units: units on a scale]
Mean ± Standard Deviation
  4.40  ± 0.74     4.07  ± 0.65     4.18  ± 0.69  
OACIS-S restricted interests score [12]
[units: units on a scale]
Mean ± Standard Deviation
  4.33  ± 0.72     4.41  ± 0.63     4.38  ± 0.65  
Hematology: Red Blood Cell (RBC) counts  
[units: *10^6 cells/µL]
Mean ± Standard Deviation
  5.1  ± 0.3     5.2  ± 0.5     5.2  ± 0.4  
Hematology: White Blood Cell (WBC) counts  
[units: *10^03 cells/µL]
Mean ± Standard Deviation
  6.9  ± 2.3     6.8  ± 1.7     6.8  ± 1.9  
Hematology: platelet counts  
[units: *10^03 cells/µL]
Mean ± Standard Deviation
  245.5  ± 47.8     251.5  ± 55.5     249.6  ± 52.6  
Blood chemistry: serum creatinine  
[units: mg/dL]
Mean ± Standard Deviation
  0.8  ± 0.1     0.8  ± 0.1     0.8  ± 0.1  
Blood Chemistry: Serum glutamic oxaloacetic transaminase (SGOT)  
[units: U/L]
Mean ± Standard Deviation
  22.8  ± 6.4     22.6  ± 8.6     22.7  ± 7.9  
Blood Chemistry: Serum glutamic pyruvic transaminase (SGPT)  
[units: U/L]
Mean ± Standard Deviation
  18.3  ± 6.1     30.0  ± 20.6     26.3  ± 18.1  
Blood chemistry: Thyroid Stimulating Hormone (TSH)  
[units: uIU/mL]
Mean ± Standard Deviation
  1.6  ± 0.9     2.0  ± 2.1     1.9  ± 1.8  
[1] 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.
[2] 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.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] 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.
[9] 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.
[10] 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.
[11] 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.
[12] 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.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 10 weeks, 18 weeks and 22 weeks ]

2.  Secondary:   Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 10 weeks, 18 weeks, 22 weeks ]

3.  Secondary:   Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 10 weeks, 18 weeks, 22 weeks ]

4.  Secondary:   Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 10 weeks, 18 weeks, 22 weeks ]

5.  Secondary:   Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 18 weeks, 22 weeks ]

6.  Secondary:   Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 18 weeks, 22 weeks ]

7.  Secondary:   Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 18 weeks, 22 weeks ]

8.  Secondary:   Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 18 weeks, 22 weeks ]

9.  Secondary:   White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 18 weeks, 22 weeks ]

10.  Secondary:   Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks   [ Time Frame: 4 weeks, 18 weeks, 22 weeks ]

11.  Secondary:   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   [ Time Frame: Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene and Protein Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks   [ Time Frame: Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andrew Zimmerman, M.D.
Organization: UMass Memorial Medical Center
phone: 508-856-3279
e-mail: Andrew.Zimmerman@umassmemorial.org


No publications provided


Responsible Party: Andrew Zimmerman, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01474993     History of Changes
Other Study ID Numbers: 2011P002221
Study First Received: November 8, 2011
Results First Received: November 4, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration