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Infant fish oil study

The immunomodulatory effects of omega-3 polyunsaturated fatty acids : role in allergy prevention

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000281594
Acronym
IFOS
Enrollment
420
Registered
2006-07-05
Start date
2005-06-01
Completion date
2010-01-10
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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.

Sponsors

Prof Susan Prescott
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

1) maternal asthma or hayfever, and atopy confirmed by skin testing (to common allergens); and 2) maternal age

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 25, 2026