Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000281594
Ethics application status
Approved
Date submitted
29/06/2006
Date registered
5/07/2006
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Date results information initially provided
6/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Infant fish oil study
Scientific title
The immunomodulatory effects of omega-3 polyunsaturated fatty acids : role in allergy prevention
Secondary ID [1] 296528 0
nil known
Universal Trial Number (UTN)
Trial acronym
IFOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic disease 1256 0
Condition category
Condition code
Inflammatory and Immune System 1342 1342 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will be randomised to receive n-3 rich fish oil (280mg docosahexanoic acid [DHA]/day; 110mg eicosapentanoic acid [EPA]/day orally; Meg 3 Ocean Nutrition, Canada) daily for the first 6 months of life.

The capsules are identical in appearance. Peppermint flavour has been added to both fish oil and placebo capsules.
Intervention code [1] 1183 0
Prevention
Comparator / control treatment
Placebo (olive oil, Ocean Nutrition, Canada) daily for the first 6 months of life.
Control group
Placebo

Outcomes
Primary outcome [1] 1829 0
Allergic sensitisation
Timepoint [1] 1829 0
Assessed at 1, 2.5 and 5 years of age
Primary outcome [2] 1830 0
Allergic disease
Timepoint [2] 1830 0
Assessed at 1, 2.5 and 5 years of age
Secondary outcome [1] 3204 0
Effects on immune development
Timepoint [1] 3204 0
At 6 and 12 months of age.

Eligibility
Key inclusion criteria
1) maternal asthma or hayfever, and atopy confirmed by skin testing (to common allergens); and 2) maternal age
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be excluded if: 1) their mother’s normal dietary intake exceeds 2 meals of fish per week 2) there are any significant pregnancy or neonatal complications including prematurity of < 36 weeks), or 3) parental smoking.

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)
Allocation was concealed and involved contacting the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible infants will be stratified by type of maternal atopy (asthma / other allergy), paternal atopic history and parity, and randomised to placebo or treatment groups. This will be performed by staff who are not involved in clinical or laboratory assessments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
10/01/2010
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
360
Accrual to date
Final
420
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1468 0
Government body
Name [1] 1468 0
NHMRC
Country [1] 1468 0
Australia
Funding source category [2] 1469 0
Commercial sector/Industry
Name [2] 1469 0
VRI Biomedical
Country [2] 1469 0
Australia
Primary sponsor type
Individual
Name
Prof Susan Prescott
Address
Country
Secondary sponsor category [1] 1296 0
University
Name [1] 1296 0
University of Western Australia
Address [1] 1296 0
Country [1] 1296 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2851 0
Princess Margaret Hospital
Ethics committee address [1] 2851 0
Ethics committee country [1] 2851 0
Australia
Date submitted for ethics approval [1] 2851 0
Approval date [1] 2851 0
21/04/2005
Ethics approval number [1] 2851 0
1111/EP

Summary
Brief summary
In this study we will compare the effects of fish oil (n=165) or placebo (n=165) in early infancy (from 0-6 months of age) on the risk of developing allergic sensitisation or allergic disease in early childhood. Both study groups will include children deemed to be at high risk of allergic disease (based on maternal allergy history).
Trial website
Trial related presentations / publications
Effects of prenatal n-3 fatty acid supplementation on offspring resolvins at birth and 12 years of age: a double-blind, randomised controlled clinical trial
VHL See, E Mas, SL Prescott, LJ Beilin, S Burrows, AE Barden, ...
British Journal of Nutrition 2017 118 (11), 971-980

Effects of postnatal omega-3 fatty acid supplementation on offspring pro-resolving mediators of inflammation at 6 months and 5 years of age: A double blind, randomized …
VHL See, E Mas, SL Prescott, LJ Beilin, S Burrows, AE Barden, ...
Prostaglandins, Leukotrienes and Essential Fatty Acids (PLEFA) 2017 126, 126-132

Does docosahexaenoic acid supplementation in term infants enhance neurocognitive functioning in infancy?AE Heaton, SJ Meldrum, JK Foster, SL Prescott, K Simmer
Frontiers in human neuroscience 2013 7, 774

Effects of high-dose fish oil supplementation during early infancy on neurodevelopment and language: a randomised controlled trial
SJ Meldrum, N D'Vaz, K Simmer, JA Dunstan, K Hird, SL Prescott
British Journal of Nutrition 2012 108 (8), 1443-1454

Postnatal fish oil supplementation in high-risk infants to prevent allergy: randomized controlled trial
N D’Vaz, SJ Meldrum, JA Dunstan, D Martino, S McCarthy, J Metcalfe, ...
Pediatrics, peds. 2012; 2011-3104

Fish oil supplementation in early infancy modulates developing infant immune responses
N D'vaz, SJ Meldrum, JA Dunstan, TF Lee-Pullen, J Metcalfe, BJ Holt, ...
Clinical & Experimental Allergy 2012;42 (8), 1206-1216

The Infant Fish Oil Supplementation Study (IFOS): Design and research protocol of a double-blind, randomised controlled n- 3 LCPUFA intervention trial in term infants
SJ Meldrum, N D'Vaz, J Dunstan, TA Mori, SL Prescott
Contemporary clinical trials 2011; 32 (5), 771-778
Public notes

Contacts
Principal investigator
Name 35427 0
Address 35427 0
Country 35427 0
Phone 35427 0
Fax 35427 0
Email 35427 0
Contact person for public queries
Name 10372 0
Prof Susan Prescott
Address 10372 0
School of Paediatrics and Child Health
Princess Margaret Hospital
Subiaco, 6008 WA
Country 10372 0
Australia
Phone 10372 0
(618) 9340 8171
Fax 10372 0
(618) 9388 2097
Email 10372 0
[email protected]
Contact person for scientific queries
Name 1300 0
Dr Jan Dunstan
Address 1300 0
School of Paediatrics and Child Health
Princess Margaret Hospital
Subiaco 6008 WA
Country 1300 0
Australia
Phone 1300 0
(618) 9388 8681
Fax 1300 0
(618) 9388 2097
Email 1300 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEffects of postnatal omega-3 fatty acid supplementation on offspring pro-resolving mediators of inflammation at 6 months and 5 years of age: A double blind, randomized controlled clinical trial.2017https://dx.doi.org/10.1016/j.plefa.2017.08.008
EmbaseDo infants of breast-feeding mothers benefit from additional long-chain PUFA from fish oil? A 6-year follow-up.2020https://dx.doi.org/10.1017/S000711452000135X
EmbaseDirect infant UV light exposure is associated with eczema and immune development.2019https://dx.doi.org/10.1016/j.jaci.2018.08.037
EmbaseA role for early oral exposure to house dust mite allergens through breast milk in IgE-mediated food allergy susceptibility.2020https://dx.doi.org/10.1016/j.jaci.2019.12.912
EmbaseOvalbumin in breastmilk is associated with a decreased risk of IgE-mediated egg allergy in children.2020https://dx.doi.org/10.1111/all.14142
EmbaseMaternal peanut and egg consumption during breastfeeding randomized pilot trial.2022https://dx.doi.org/10.1111/pai.13845
N.B. These documents automatically identified may not have been verified by the study sponsor.