Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090428
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2004-08-26
Brief Title:
Diet and Behavior in Young Children With Autism
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Diet and Behavior in Young Children With Autism
Status:
COMPLETED
Status Verified Date:
2013-01
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:
None
Brief Summary:
This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism
Detailed Description:
Autism is a serious brain disorder that affects brain development and often causes social and educational problems Prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism This study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria are monitored in adherence to the diet and receive similar intense behavioral therapy
Children in this study will be following a gluten free and casein free diet for 18 weeks All subjects will have 6 weeks of baseline followed by 12 weeks of randomized double-blind placebo-controlled challenge snacks with careful behavioral observation and evaluation They also will be receiving uniform educational and behavioral services through their provider Standard autism evaluation methods weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects An end of study follow-up assessment will be completed at 30 weeks after the start of the study
Children in this study will be following a gluten free and casein free diet for 18 weeks All subjects will have 6 weeks of baseline followed by 12 weeks of randomized double-blind placebo-controlled challenge snacks with careful behavioral observation and evaluation They also will be receiving uniform educational and behavioral services through their provider Standard autism evaluation methods weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects An end of study follow-up assessment will be completed at 30 weeks after the start of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DDTR BD-DD | US NIH GrantContract | None | httpsreporternihgovquickSearchU54MH066397 |
| U54MH066397 | NIH | None | None |