Six year follow up of children at high hereditary risk of allergy born to mothers participating in the DOMInO Trial.

Six year follow up of a randomised controlled trial to compare maternal omega-3 long chain poly-unsaturated fatty acids (n-3 LCPUFA) supplementation versus vegetable oil in pregnancy, on allergic disease outcomes in the school age child

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000498594

Acronym

DOMInO 6

Enrollment

668

Registered

2015-05-19

Start date

2012-04-10

Completion date

2014-08-22

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

The aim of the 6 year allergy follow up is to see if taking fish oil supplements during pregnancy can reduce the development of allergies in children and how long these effects may last. At 1 year of age, we found that there were fewer children with atopic eczema and fewer children with a positive skin prick test to egg in the group whose mothers took fish oil supplements during pregnancy than those in the control group that took vegetable oil capsules. As children reach school age we expect asthma and hayfever to become more common and by examining all children at 6 years of age, we will be able see whether the effects of fish oil supplementation during pregnancy are long standing or are only seen in early childhood.

Interventions

This study is a follow up children born to women participating in the DOMInO Trial: ACTRN12605000569606. Women were asked to consume 3 x 500mg DHA rich Tuna Oil capsules daily from 18-21 weeks gestation until birth of child.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

6 Years to 7 Years

Healthy volunteers

Yes

Inclusion criteria

Child was consented to nested 1 and 3 year allergy cohort of the DOMInO trial prior to birth with family history of medically diagnosed allergic disease (eczema, asthma, allergic rhinitis): Women in DOMInO trial had 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

Exclusion criteria

Maternal bleeding disorders where DHA tuna oil is contraindicated

Outcome results