Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000144516
Ethics application status
Approved
Date submitted
29/10/2014
Date registered
16/02/2015
Date last updated
6/07/2024
Date data sharing statement initially provided
6/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Omega-3, vitamin D and Autism in children
Scientific title
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
Secondary ID [1] 284618 0
nil known
Universal Trial Number (UTN)
U1111-1156-9537
Trial acronym
VIDOMA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorder 291925 0
Condition category
Condition code
Mental Health 292279 292279 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289396 0
Treatment: Other
Comparator / control treatment
4xplacebo per day; Capsules containing 750mg vegetable oil in gel capsules with tear-off nipple allowing oil to be mixed with food. Administered daily with food for 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 293552 0
Change in behaviour and social interaction; Will be assessed by Social Responsiveness Scale-2 (SRS-2)
Timepoint [1] 293552 0
12 months after commencement of intervention
Primary outcome [2] 293553 0
Change in sensory profile; Will be assessed by Sensory Processing Measure (SPM)
Timepoint [2] 293553 0
12 months after commencement of intervention
Primary outcome [3] 297425 0
Change in problem behaviours; Will be assessed by Aberrant Behaviour Checklist (ABC)
Timepoint [3] 297425 0
12 months after commencement of intervention
Secondary outcome [1] 311347 0
Gastrointestinal symptoms as monitored by weekly diary of symptoms by parent or caregiver.
Timepoint [1] 311347 0
12 months after commencement of intervention

Eligibility
Key inclusion criteria
Medical diagnosis of autism spectrum disorder, onset after 18 months of age
Minimum age
2 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children will be recruited and allocated to a quartet by age. This is important to ensure that there is as close as possible range of ages in each of the four treatment groups. Allocation concealment will be carried out by a third party who is unaware of who, when and to which group the eligible subject is allocated. This person will generate randomisation using WinPepi program (balanced randomisation of random blocks stratified by age and autism severity).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each quartet will be assigned to treatments using a random block method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
this is a 4-arm, placebo controlled trial
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is calculated based on the main outcome measure, SRS-2.. It was calculated that 42 participants (a minimum of 34 participants, and allowing for a 20% potential dropout rate) would be required for each arm of the trial to demonstrate a significant difference at 80% power and 5% significance. Power calculations were based on a 17 units difference between supplemented groups and placebo in change from baseline to endpoint on the Social Responsiveness Scale (SRS) total score, on a mean SRS and standard deviation of 105 and 24.7 units in untreated children with ASD, respectively (from our pilot study, unpublished)..
Statistical analysis will be performed using IBM SPSS version 21.0 (IBM Corporation, New York, US). The variables will be tested for normality using the Kolmogorov-Smirnov, Shapiro-Wilk tests and normality plots. Non-normally distributed data will be transformed into approximate normal distributions by logarithmic transformations. The data will be reported appropriately as mean (95%CI) for normally distributed data; transformed data will be back transformed from summary statistics into mean (95% CI), non-normally distributed data will be described as median (25, 75 percentiles) and categorical data as frequencies. Baseline characteristics of participants will be compared among groups using analysis of variance (ANOVA). The primary analysis, comparing the effects of treatment on symptoms of autism over 12-months, will be conducted using a generalised linear mixed models procedure. Treatments and time will be included as fixed effects and the interactions between interventions and time will be tested. If significant main effects or interaction effects are observed, post-hoc analysis with Bonferroni adjustments will be performed. Potential confounding factors and effect modifiers (e.g. gender, age, biochemistry, baseline symptoms of autism) will be investigated within the model. A P-value of <0.05 will be considered statistical significant.

Compliance to treatment will be analysed by counting each participant’s remaining supplements once they have completed the intervention. Differences between participants who completed and withdrew will be analysed using independent t test or Mann-Whitney tests for continuous variables (e.g. age) and chi-square for categorical variables (e.g. gender). Statistical significance will be based on two-tailed tests, with p <0.05 considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2015
Actual
1/02/2015
Date of last participant enrolment
Anticipated
1/08/2016
Actual
25/07/2016
Date of last data collection
Anticipated
Actual
15/08/2017
Sample size
Target
168
Accrual to date
Final
119
Recruitment outside Australia
Country [1] 6443 0
New Zealand
State/province [1] 6443 0
Auckland

Funding & Sponsors
Funding source category [1] 290163 0
University
Name [1] 290163 0
Massey University
Country [1] 290163 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University Albany
Private Bag 102904
North Shore
Auckland
0745
Country
New Zealand
Secondary sponsor category [1] 288871 0
Government body
Name [1] 288871 0
Waitemata District Health Board
Address [1] 288871 0
124 Shakespeare Road
Takapuna
AUCKLAND 0622
Private Bag 93-503
Takapuna
AUCKLAND 0740
Country [1] 288871 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291871 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 291871 0
Ethics committee country [1] 291871 0
New Zealand
Date submitted for ethics approval [1] 291871 0
14/07/2014
Approval date [1] 291871 0
25/08/2014
Ethics approval number [1] 291871 0
14/NTA/113

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48490 0
Prof Pamela von Hurst
Address 48490 0
Professor Emerita, School of Sport, Exercise and Nutrition, College of Health, Massey University, Albany Campus, Private Bag 102904, North Shore City, 0745, Auckland
Country 48490 0
New Zealand
Phone 48490 0
+649 4140800 ext 43657
Fax 48490 0
Email 48490 0
[email protected]
Contact person for public queries
Name 48491 0
Delete - no longer at Massey University
Address 48491 0
as above
Country 48491 0
New Zealand
Phone 48491 0
+649 4140800
Fax 48491 0
Email 48491 0
[email protected]
Contact person for scientific queries
Name 48492 0
Remove - now retired
Address 48492 0
as above
Country 48492 0
New Zealand
Phone 48492 0
+649 4140800 ext 43657
Fax 48492 0
Email 48492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: A study protocol for a factorial randomised, double-blind, placebo-controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1428-8
EmbaseA randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder.2019https://dx.doi.org/10.1016/j.jsbmb.2018.10.017
EmbaseA Randomised-Controlled Trial of Vitamin D and Omega-3 Long Chain Polyunsaturated Fatty Acids in the Treatment of Core Symptoms of Autism Spectrum Disorder in Children.2019https://dx.doi.org/10.1007/s10803-018-3860-y
EmbaseInflammation (Il-1beta) modifies the effect of vitamin d and omega-3 long chain polyunsaturated fatty acids on core symptoms of autism spectrum disorder-an exploratory pilot study++.2020https://dx.doi.org/10.3390/nu12030661
N.B. These documents automatically identified may not have been verified by the study sponsor.