Omega-3, vitamin D and Autism in childre

Phase 4

Completed

• Conditions: Autism spectrum disorder; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12615000144516
• Lead Sponsor: Massey University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Study Completion: 2017-08-15
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Medical diagnosis of autism spectrum disorder, onset after 18 months of age; Medical diagnosis of autism spectrum disorder, onset after 18 months of age

Exclusion Criteria

Children with winter 25(OH)D concentration > 75 nmol/L (+10 nmol/L assay variation) and summer 25(OH)D concentration > 105 nmol/L (+10 nmol/L assay variation) at baseline; Children with winter 25(OH)D concentration > 75 nmol/L (+10 nmol/L assay variation) and summer 25(OH)D concentration > 105 nmol/L (+10 nmol/L assay variation) at baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in behaviour and social interaction; Will be assessed by Social Responsiveness Scale-2 (SRS-2) [ 12 months after commencement of intervention];Change in sensory profile; Will be assessed by Sensory Processing Measure (SPM) [ 12 months after commencement of intervention];Change in problem behaviours; Will be assessed by Aberrant Behaviour Checklist (ABC)[ 12 months after commencement of intervention];Change in behaviour and social interaction; Will be assessed by Social Responsiveness Scale-2 (SRS-2) [ 12 months after commencement of intervention];Change in sensory profile; Will be assessed by Sensory Processing Measure (SPM) [ 12 months after commencement of intervention];Change in problem behaviours; Will be assessed by Aberrant Behaviour Checklist (ABC)[ 12 months after commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms as monitored by weekly diary of symptoms by parent or caregiver.[ 12 months after commencement of intervention];Gastrointestinal symptoms as monitored by weekly diary of symptoms by parent or caregiver.[ 12 months after commencement of intervention]