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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]

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

Condition category

Condition code

Mental Health

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]

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]

Change in behaviour and social interaction; Will be assessed by Social Responsiveness Scale-2 (SRS-2)

Timepoint [1]

12 months after commencement of intervention

Primary outcome [2]

Change in sensory profile; Will be assessed by Sensory Processing Measure (SPM)

Timepoint [2]

12 months after commencement of intervention

Primary outcome [3]

Change in problem behaviours; Will be assessed by Aberrant Behaviour Checklist (ABC)

Timepoint [3]

12 months after commencement of intervention

Secondary outcome [1]

Gastrointestinal symptoms as monitored by weekly diary of symptoms by parent or caregiver.

Timepoint [1]

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?

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Massey University

Address [1]

Massey University Albany
Private Bag 102904
North Shore
Auckland
0745

Country [1]

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]

Government body

Name [1]

Waitemata District Health Board

Address [1]

124 Shakespeare Road
Takapuna
AUCKLAND 0622
Private Bag 93-503
Takapuna
AUCKLAND 0740

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disabilities Ethics Committee

Ethics committee address [1]

Ministry of Health
10 Brandon Street
PO Box 5013
Wellington 6145

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

14/07/2014

Approval date [1]

25/08/2014

Ethics approval number [1]

14/NTA/113

Summary

Brief summary

Internationally, prevalence of autism appears to be increasing but the cause is unknown. In New Zealand one child in every 100 is diagnosed with a condition on the autism spectrum. Both vitamin D and Omega-3 polyunsaturated fatty acids are known to play a number of roles in brain development and behaviour. The VIDOMA trial will investigate the effect of supplementing these important nutrients in the diet of 168 young children with autism spectrum disorder. Children will take the supplements for one year and investigators will measure changes in symptoms such as social-communicative functioning, sensory processing profile, problem behaviours and gastrointestinal symptoms..

Trial website

Trial related presentations / publications

22.	Hajar Mazahery, Cathryn A. Conlon, Kathryn L. Beck, Owen Mugridge, Marlena C. Kruger, Welma Stonehouse, Carlos A. Camargo Jr., Barbara J. Meyer, Bobby Tsang, Pamela R von Hurst. 2020. Inflammation (IL-1ß) modifies the effect of vitamin D and omega-3 long chain polyunsaturated fatty acids on core symptoms of Autism Spectrum Disorder. Nutrients 12(3), 661; https://doi.org/10.3390/nu12030661

28.	Hajar Mazahery, Cathryn A. Conlon, Kathryn L. Beck, Owen Mugridge, Marlena C. Kruger, Welma Stonehouse, Carlos A. Camargo Jr., Barbara J. Meyer, Bobby Tsang, Beatrix Jones, Pamela R. von Hurst. (2019) A 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. Journal of Autism and Developmental Disorders. First published online: 4 January 2019. https://doi.org/10.1007/s10803-018-3860-y

30.	Hajar Mazahery, Cathryn A. Conlon, Kathryn L. Beck, Owen Mugridge, Marlena C. Kruger, Welma Stonehouse, Carlos A. Camargo Jr, Barbara J. Meyer, Beatrix Jones, Pamela R. von Hurst. A 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. Journal of Steroid Biochemistry and Molecular Biology First published version available online: 26-OCT-2018 DOI information: 10.1016/j.jsbmb.2018.10.017

36.	Hajar Mazahery, Welma Stonehouse, Maryam Delshad, Marlena C. Kruger, Cathryn A. Conlon, Kathryn L. Beck, Pamela R. von Hurst. (2017) Relationship between Long Chain n-3 Polyunsaturated Fatty Acids and Autism Spectrum Disorder: Systematic Review and Meta-Analysis of Case-Control and Randomised Controlled Trials. Nutrients 2017, 9(2), 155; doi: 10.3390/nu9020155

39.	H Mazahery, C Conlon, K Beck, MC Kruger, W Stonehouse, C A Camargo Jnr, B Meyer, B Tsang, O Mugridge, P R von Hurst. (2016) Vitamin 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. Trials, 17:295 (23 June 2016

Public notes

Contacts

Principal investigator

Name

Prof Pamela von Hurst

Address

Professor Emerita, School of Sport, Exercise and Nutrition, College of Health, Massey University, Albany Campus, Private Bag 102904, North Shore City, 0745, Auckland

Country

New Zealand

Phone

+649 4140800 ext 43657

Fax

p.r.vonhurst@massey.ac.nz

Contact person for public queries

Name

Delete - no longer at Massey University

Address

as above

Country

New Zealand

Phone

+649 4140800

Fax

o.mugridge@massey.ac.nz

Contact person for scientific queries

Name

Remove - now retired

Address

as above

Country

New Zealand

Phone

+649 4140800 ext 43657

Fax

p.r.vonhurst@massey.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Vitamin 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.	2016	https://dx.doi.org/10.1186/s13063-016-1428-8
Embase	A 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.	2019	https://dx.doi.org/10.1016/j.jsbmb.2018.10.017
Embase	A 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.	2019	https://dx.doi.org/10.1007/s10803-018-3860-y
Embase	Inflammation (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++.	2020	https://dx.doi.org/10.3390/nu12030661

N.B. These documents automatically identified may not have been verified by the study sponsor.

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