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Trial registered on ANZCTR


Registration number
ACTRN12610000735055
Ethics application status
Approved
Date submitted
2/09/2010
Date registered
3/09/2010
Date last updated
25/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish oil supplementation in pregnancy to reduce allergies in early childhood
Scientific title
Early childhood follow up of a randomised controlled trial to compare maternal docosahexanoeic acid (DHA) rich tuna oil versus vegetable oil supplementation in pregnancy on child allergic disease outcomes.
Secondary ID [1] 252621 0
National Health and Medical Research Council (NHMRC) ID 399389
Universal Trial Number (UTN)
Trial acronym
DHAllergy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Disease 258115 0
Condition category
Condition code
Inflammatory and Immune System 258291 258291 0 0
Allergies
Alternative and Complementary Medicine 258300 258300 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 x 500mg high-DHA rich tuna oil capsules per day taken from 18-21 weeks gestation until birth
Intervention code [1] 257133 0
Prevention
Comparator / control treatment
3 x 500mg blended vegetable oil capsules per day
Control group
Placebo

Outcomes
Primary outcome [1] 259142 0
Medical diagnosis (from a clinical examination) of allergic disease (eczema, asthma, allergic rhinitis or food allergy) with sensitisation (determined by a positive skin prick test to food allergens or aeroallergens) in the child
Timepoint [1] 259142 0
At 1 and 3 years of age
Secondary outcome [1] 265464 0
Medical diagnosis (from a clinical examination) of allergic disease (eczema, asthma, allergic rhinitis or food allergy) without sensitisation in the child
Timepoint [1] 265464 0
At 1 and 3 years of age
Secondary outcome [2] 265465 0
Any Sensitisation (determined by a positive skin prick test to food allergens or aeroallergens) in the child
Timepoint [2] 265465 0
At 1 and 3 years of age

Eligibility
Key inclusion criteria
Child to have a family history of medically diagnosed allergic disease (eczema, asthma, allergic rhinitis):
singleton pregnancy less than 18-21 weeks gestation with no known fetal abnormality: mothers not to have had documented history of alcohol or drug abuse: no participation in other clinical trials with fatty acid intervention.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternal bleeding disorders where DHA tuna oil is contraindicated

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
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?



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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3214 0
5006
Recruitment postcode(s) [2] 3215 0
5042

Funding & Sponsors
Funding source category [1] 257582 0
Government body
Name [1] 257582 0
National Health and Medical Research Council
Address [1] 257582 0
GPO Box 1421 Canberra ACT 2601
Country [1] 257582 0
Australia
Primary sponsor type
Government body
Name
Women's and Children's Health Research Institute
Address
Level 7
72 King William Rd
North Adelaide SA
5006
Country
Australia
Secondary sponsor category [1] 256818 0
None
Name [1] 256818 0
Address [1] 256818 0
Country [1] 256818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259608 0
Children, Youth and Women's Health Services
Ethics committee address [1] 259608 0
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 259608 0
Australia
Date submitted for ethics approval [1] 259608 0
28/11/2005
Approval date [1] 259608 0
14/12/2005
Ethics approval number [1] 259608 0
REC1657/12/2007

Summary
Brief summary
DHA is an omega-3 fat found in fish and fish oils and is thought to effect an infant's developing immune system. While in the womb, the baby is supplied with DHA from the mothers circulation. This study will help determine whether increasing the amount of DHA in the diet of pregnant women reduces allergies in their children.
Trial website
Trial related presentations / publications
Palmer DJ, Sullivan T, Gold MS, Prescott SL, Heddle R, Gibson RA, Makrides M. Effect of n-3 long chain polyunsaturated fatty acids (LCPUFA) supplementation in pregnancy on infant allergies in the first year of life: a randomised controlled trial. BMJ 2012; 344: e184

DJ Palmer, T Sullivan, MS Gold, SL Prescott, R Heddle, RA Gibson, M Makrides. Randomised controlled trial of fish oil supplementation in pregnancy on childhood allergies. Allergy 2013; 68(11):1370-6
Public notes

Contacts
Principal investigator
Name 31597 0
Prof Maria Makrides
Address 31597 0
Child Nutrition Research Centre Women's and Children's Health Research Institute 72 King William Rd North Adelaide SA 5006
Country 31597 0
Australia
Phone 31597 0
+61 8 8161 6067
Fax 31597 0
Email 31597 0
maria.makrides@health.sa.gov.au
Contact person for public queries
Name 14844 0
Prof Maria Makrides
Address 14844 0
Child Nutrition Research Centre
Women's and Children's Health Research Institute
72 King William Rd
North Adelaide SA 5006
Country 14844 0
Australia
Phone 14844 0
+61 8 8161 6067
Fax 14844 0
+61 8 81618228
Email 14844 0
maria.makrides@health.sa.gov.au
Contact person for scientific queries
Name 5772 0
Dr Debbie Palmer
Address 5772 0
Childhood Allergy and Immunology Research
School of Paediatrics and Child Health
University of Western Australia
Roberts Road Subiaco WA 6008
Country 5772 0
Australia
Phone 5772 0
+61 8 9340 8681
Fax 5772 0
+61 8 9388 2097
Email 5772 0
debbie.palmer@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary