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| Sponsor: | Center for Autisme, Denmark |
|---|---|
| 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 |
| ClinicalTrials.gov Identifier: | NCT00614198 |
Purpose
A growing body of research indicates that dietary intervention excluding foods containing the proteins, gluten and casein, from the diet of children diagnosed with an autism spectrum disorder (ASD) may have a positive effect on behaviour and developmental outcome.
In this single-blind, randomised-controlled, matched-pair adaptive trial, we introduced a gluten- and casein-free (GFCF) diet to a group of pre-pubescent children diagnosed with ASD concurrently with an abnormal urinary profile. Following random allocation to a diet or non- diet group, stage 1 of the study saw an intervention group follow the GFCF diet for eight months initially - progressing to 12 months if required. A non-diet control group continued with a normal diet.
Assuming significant changes for the dietary group on the various outcome measures of behaviour and development, stage 2 of the study saw both groups assigned to GFCF dietary intervention for a further 12 months when outcome measures were again assessed at study end.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism Autism Spectrum Disorder (ASD) |
Other: Gluten- and casein-free diet |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | The ScanBrit Randomised Controlled Study of Gluten- and Casein-free Dietary Intervention for Children With Autism Spectrum Disorders |
| Enrollment: | 72 |
| Study Start Date: | April 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gluten- and casein-free diet
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 improvements then progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
|
Other: Gluten- and casein-free diet
Removal of foods containing gluten (cereal produce) and casein (dairy produce)
Other Name: Gluten-free (wheat-free), casein- free (milk-free) diets
|
|
No Intervention: No 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 gluten- and casein-free dietary group showed group significant improvements then progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
|
Eligibility criteria: diagnosis of autism, no co-morbid diagnosis of Fragile X syndrome, epilepsy or tuberous sclerosis, aged between 4-10y11m.
Experimental hypothesis: children with an autism spectrum disorder (ASD) on a GFCF diet would show a significantly improved group developmental outcome in the medium- and long-term with regards to core autism and/or secondary symptoms.
Main outcome measures: change in scores of dietary participants on one or more measures against predefined statistical thresholds as evidence of improvement, alongside changes to intra- and inter-group scores at study endpoint.
Main outcome measures ascertained by: Autism Diagnostic Observation Schedule (ADOS), Gillam Autism Rating Scale (GARS), Vineland Adaptive Behaviour Scales (VABS), Attention Deficit Hyperactivity Disorder - IV (ADHD-IV) scales.
Eligibility| Ages Eligible for Study: | 4 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Director Demetrious Haracopos, Center for Autisme |
| ClinicalTrials.gov Identifier: | NCT00614198 History of Changes |
| Other Study ID Numbers: | KA 0503g |
| Study First Received: | January 31, 2008 |
| Results First Received: | May 17, 2010 |
| Last Updated: | August 31, 2010 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
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autism autism spectrum disorder diet gluten casein intervention peptide |
randomised controlled adaptive design Autism Diagnostic Observation Schedule (ADOS) Gilliam Autism Rating Scale (GARS) Vineland Adaptive Behaviour Scale (VABS) Attention-Deficit Hyperactivity Disorder (ADHD)-IV Scale |
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Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
Caseins Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
