Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00614198
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
2008-01-31
Brief Title:
ScanBrit Dietary Intervention in Autism
Sponsor:
Center for Autisme Denmark
Organization:
Center for Autisme Denmark
Study Overview
Official Title:
The ScanBrit Randomised Controlled Study of Gluten- and Casein-free Dietary Intervention for Children With Autism Spectrum Disorders
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ScanBrit
Brief Summary:
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
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
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None