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
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
Trial website
Trial related presentations / publications
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
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
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
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.