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document
The ScanBrit randomised , controlled , single-blind study of a gluten- and casein-free dietary intervention for children with autism spectrum disorders . There is increasing interest in the use of gluten- and casein-free diets for children with autism spectrum disorders ( ASDs ) . We report results from a two-stage , 24-month , randomised , controlled trial incorporating an adaptive 'catch-up ' design and interim analysis . Stage 1 of the trial saw 72 Danish children ( aged 4 years to 10 years 11 months ) assigned to diet ( A ) or non-diet ( B ) groups by stratified randomisation . Autism Diagnostic Observation Schedule ( ADOS ) and the Gilliam Autism Rating Scale ( GARS ) were used to assess core autism behaviours , Vineland Adaptive Behaviour Scales ( VABS ) to ascertain developmental level , and Attention-Deficit Hyperactivity Disorder - IV scale ( ADHD-IV ) to determine inattention and hyperactivity . Participants were tested at baseline , 8 , and 12 months . Based on per protocol repeated measures analysis , data for 26 diet children and 29 controls were available at 12 months . At this point , there was a significant improvement to mean diet group scores ( time*treatment interaction ) on sub-domains of ADOS , GARS and ADHD-IV measures . Surpassing of predefined statistical thresholds as evidence of improvement in group A at 12 months sanctioned the re-assignment of group B participants to active dietary treatment . Stage 2 data for 18 group A and 17 group B participants were available at 24 months . Multiple scenario analysis based on inter- and intra-group comparisons showed some evidence of sustained clinical group improvements although possibly indicative of a plateau effect for intervention . Our results suggest that dietary intervention may positively affect developmental outcome for some children diagnosed with ASD . In the absence of a placebo condition to the current investigation , we are , however , unable to disqualify potential effects derived from intervention outside of dietary changes . Further studies are required to ascertain potential best- and non-responders to intervention . The study was registered with ClincialTrials.gov , number NCT00614198 .
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Intervention_Pharmacological
gluten- and casein-free dietary intervention
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Intervention_Pharmacological
gluten- and casein-free diets
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Intervention_Control
non-diet
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Intervention_Pharmacological
dietary intervention
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Intervention_Control
placebo
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Outcome_Mental
Autism Diagnostic Observation Schedule ( ADOS ) and the Gilliam Autism Rating Scale ( GARS )
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Outcome_Mental
core autism behaviours
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Outcome_Mental
Vineland Adaptive Behaviour Scales ( VABS )
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Outcome_Mental
developmental level
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Outcome_Mental
Attention-Deficit Hyperactivity Disorder - IV scale ( ADHD-IV ) to determine inattention and hyperactivity .
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Outcome_Mental
ADOS , GARS and ADHD-IV measures .
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Participant_Age
children
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Participant_Condition
autism spectrum disorders
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Participant_Sample-size
72
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Participant_Age
aged 4 years to 10 years 11 months
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Participant_Sample-size
26 diet children
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Participant_Sample-size
29 controls