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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000144516 |
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Date of registration:
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16/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Omega-3, vitamin D and Autism in children
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Scientific title:
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Effect of Vitamin D and Omega-3 Fatty Acid Supplements on behavioural measures in Children with Autism Spectrum Disorder (ASD): A randomised, double-blind, placebo-controlled trial
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Date of first enrolment:
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01/02/2015 |
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Target sample size:
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168 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000144516.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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New Zealand
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Contacts
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Name:
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Dr Pamela von Hurst
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Address:
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Division of Human Nutrition and Dietetics
College of Health
Massey University, Albany campus
Private bag 102904
North Shore City, 0745, Auckland
New Zealand |
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Telephone:
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+649 4140800 ext 43657 |
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Email:
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p.r.vonhurst@massey.ac.nz |
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Affiliation:
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Name:
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Mr Owen Mugridge
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Address:
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Division of Human Nutrition and Dietetics
College of Health
Massey University Albany campus
Private bag 102904
North Shore City, 0745, Auckland
New Zealand |
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Telephone:
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+649 4140800 |
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Email:
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o.mugridge@massey.ac.nz |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Age minimum:
2 Years
Age maximum:
8 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Autism spectrum disorder;
Autism spectrum disorder
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Mental Health - Autistic spectrum disorders
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Intervention(s)
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An RCT with 3 treatment arms:
1: Omega-3, high DHA (722mg) fish oil; 2xomega-3 (total DHA dose = 722mg/day) per day + 2xplacebo per day
2:Vitamin D3, 2000IU; 2xvitamin D3 (1000IU/capsule) per day + 2xplacebo per day
3: Omega-3 (722mg DHA) and vitamin D3 (2000IU); 2xomega-3 (total DHA dose = 722mg/day) per day+2xvitamin D3 (1000IU/capsule) per day
All in gel capsules with tear-off nipple allowing oil to be mixed with food. Administered daily with food for 12 months.
Compliance monitored with diary and pill counting in returned bottles.
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Primary Outcome(s)
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Change in sensory profile; Will be assessed by Sensory Processing Measure (SPM) [12 months after commencement of intervention]
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Change in behaviour and social interaction; Will be assessed by Social Responsiveness Scale-2 (SRS-2) [12 months after commencement of intervention]
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Change in problem behaviours; Will be assessed by Aberrant Behaviour Checklist (ABC)[12 months after commencement of intervention]
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Secondary Outcome(s)
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Gastrointestinal symptoms as monitored by weekly diary of symptoms by parent or caregiver.[12 months after commencement of intervention]
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Secondary ID(s)
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nil known
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Source(s) of Monetary Support
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Massey University
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Ethics review
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Status: Approved
Approval date:
Contact:
Health and Disabilities Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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