Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000770662
Ethics application status
Approved
Date submitted
10/07/2014
Date registered
21/07/2014
Date last updated
2/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
7 year follow-up of children whose mothers participated in the DOMInO study.
Scientific title
Does n-3 LCPUFA supplementation during pregnancy improve the intelligence quotient of children at school age?
Secondary ID [1] 284745 0
nil
Universal Trial Number (UTN)
Trial acronym
The DOMInO 7 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive development 292111 0
Condition category
Condition code
Diet and Nutrition 292443 292443 0 0
Other diet and nutrition disorders
Mental Health 292444 292444 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.5g DHA rich Tuna Oil Capsules taken daily from 18-21 weeks until birth of child in The DOMInO 7 Study.
Intervention code [1] 289530 0
Prevention
Comparator / control treatment
0.5g Blended Vegetable Oil Capsules
Control group
Placebo

Outcomes
Primary outcome [1] 292303 0
General IQ at 7 years of age will be assessed using the WASI version II.
Timepoint [1] 292303 0
7 years corrected age.
Secondary outcome [1] 308681 0
Executive function will be assessed with the Rey Complex Figure (RCF) and the Fruit Stroop test (F-Stroop);
Timepoint [1] 308681 0
7 years corrected age.
Secondary outcome [2] 309475 0
Attention will be assessed using subtests from the Test of Everyday Attention for Children (TEACh);
Timepoint [2] 309475 0
7 years corrected age.
Secondary outcome [3] 309476 0
Memory & learning will be assessed with the Rey Auditory Verbal Learning Test (RAVLT);
Timepoint [3] 309476 0
7 years corrected age.
Secondary outcome [4] 309477 0
Behaviour will be evaluated with parent versions of the Strength and Difficulties Questionnaire (SDQ).
Timepoint [4] 309477 0
7 years corrected age.

Eligibility
Key inclusion criteria
children who were included in the 4yr developmental follow up of the original DOMInO trial.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central telephone and mail
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated balanced variable blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
1/03/2013
Date of last participant enrolment
Anticipated
31/07/2015
Actual
12/09/2016
Date of last data collection
Anticipated
31/07/2015
Actual
12/09/2016
Sample size
Target
686
Accrual to date
Final
543
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8257 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 289359 0
Government body
Name [1] 289359 0
NH&MRC
Country [1] 289359 0
Australia
Primary sponsor type
Government body
Name
NH&MRC
Address
National Health and Medical Research Council
GPO BOX 1421
CANBERRA ACT 2601
Country
Australia
Secondary sponsor category [1] 288044 0
None
Name [1] 288044 0
Address [1] 288044 0
Country [1] 288044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291125 0
Children, Youth and Women's Health Services
Ethics committee address [1] 291125 0
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 291125 0
Australia
Date submitted for ethics approval [1] 291125 0
04/02/2013
Approval date [1] 291125 0
08/02/2013
Ethics approval number [1] 291125 0
HREC/12/WCHN/112

Summary
Brief summary
This study aims to determine whether DHA supplementation during pregnancy enhances child IQ, measured by the Wechsler Abbreviated Scale of Intelligence (WASI II) version II, at 7 years of age.
hypthesis: Children who were exposed to a DHA-rich environment during the second half of gestation will have higher IQ scores at 7 years of age than children whose mothers consumed a regular Australian diet typically low in DHA.
Trial website
na
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48998 0
Prof Maria Makrides
Address 48998 0
SAHMRI Healthy Mothers, Babies and Children theme
Level 7, CRB Women's and Children's Hospital 72 King William Road North Adelaide SA 5006 AUSTRALIA
Country 48998 0
Australia
Phone 48998 0
+61 (0)8 8161 6067
Fax 48998 0
+61 (0)8 8239 0267
Email 48998 0
[email protected]
Contact person for public queries
Name 48999 0
Dr Jacqueline Gould
Address 48999 0
SAHMRI Healthy Mothers, Babies and Children theme
Level 7, CRB Women's and Children's Hospital 72 King William Road North Adelaide SA 5006 AUSTRALIA
Country 48999 0
Australia
Phone 48999 0
+61 (0)8 8161 6067
Fax 48999 0
+61 (08) 8204 6296
Email 48999 0
[email protected]
Contact person for scientific queries
Name 49000 0
Dr Jacqueline Gould
Address 49000 0
SAHMRI Healthy Mothers, Babies and Children theme
Level 7, CRB Women's and Children's Hospital 72 King William Road North Adelaide SA 5006 AUSTRALIA
Country 49000 0
Australia
Phone 49000 0
+61 (08) 8161 7071
Fax 49000 0
+61 (0)8 8239 0267
Email 49000 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.