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ScanBrit Dietary Intervention in Autism (ScanBrit)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614198
First Posted: February 13, 2008
Last Update Posted: October 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Norway: Bo Nils og Seim Family Settlement
The Robert Luff Foundation, United Kingdom
Eric Birger Christensen Fond, Denmark
Norsk Proteinintolerance, Norway
Information provided by:
Center for Autisme, Denmark
Results First Submitted: May 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions: Autism
Autism Spectrum Disorder (ASD)
Intervention: Other: Gluten- and casein-free diet

  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
Recruitment via multiple associations

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
92 participants were initially identified for possible study recruitment. 82 participants were available for possible study allocation; 10 participants dropped out prior to randomisation for various reasons, leaving 72 participants.

Reporting Groups
  Description
Gluten- and Casein-free Dietary Intervention Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
No Gluten- and Casein-free Dietary Intervention Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).

Participant Flow for 2 periods

Period 1:   Stage 1
    Gluten- and Casein-free Dietary Intervention   No Gluten- and Casein-free Dietary Intervention
STARTED   38   34 
COMPLETED   26   29 
NOT COMPLETED   12   5 

Period 2:   Stage 2
    Gluten- and Casein-free Dietary Intervention   No Gluten- and Casein-free Dietary Intervention
STARTED   26   29 [1] 
COMPLETED   18   17 
NOT COMPLETED   8   12 
[1] Reallocated to gluten- and casein-free dietary intervention



  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
Gluten- and Casein-free Dietary Intervention Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
No Gluten- and Casein-free Dietary Intervention Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
Total Total of all reporting groups

Baseline Measures
   Gluten- and Casein-free Dietary Intervention   No Gluten- and Casein-free Dietary Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   34   72 
Age 
[Units: Participants]
     
<=18 years   38   34   72 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.22  (1.99)   8.13  (2.03)   8.15  (2) 
Gender 
[Units: Participants]
     
Female   5   3   8 
Male   33   31   64 
Region of Enrollment 
[Units: Participants]
     
Denmark   38   34   72 


  Outcome Measures

1.  Primary:   Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement.   [ Time Frame: Baseline - 8 months - 12 months - 24 months ]

2.  Secondary:   Changes to Appearance of Multiple Compounds in Urine Samples   [ Time Frame: Baseline - 8 months -12 months - 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Single-blind trial, no placebo condition, analysis based on per protocol (not intention to treat), socio-economic status not recorded, independent screening for underlying somatic conditions potentially associated with results not undertaken


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lennart Pedersen
Organization: Center for Autisme
phone: 44982355
e-mail: lpe@centerforautisme.dk


Publications of Results:

Responsible Party: Director Demetrious Haracopos, Center for Autisme
ClinicalTrials.gov Identifier: NCT00614198     History of Changes
Other Study ID Numbers: KA 0503g
First Submitted: January 31, 2008
First Posted: February 13, 2008
Results First Submitted: May 17, 2010
Results First Posted: October 1, 2010
Last Update Posted: October 1, 2010