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Trial registered on ANZCTR

Registration number

ACTRN12611000041954

Ethics application status

Approved

Date submitted

10/01/2011

Date registered

12/01/2011

Date last updated

15/12/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Allergy Prevention Study Using Fish oil in Pregnancy

Scientific title

Studies fish oil maternal diet in pregnancy to prevent allergy: the effects of maternal n-3 PUFA ( fish oil) supplementation on neonatal immune responses

Secondary ID [1]

PMH 358/EP

Universal Trial Number (UTN)

Trial acronym

APP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Allergy

Condition category

Condition code

Inflammatory and Immune System

Allergies

Reproductive Health and Childbirth

Normal pregnancy

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Women in the fish oil group received 4 (1-g) fish oil capsules per
day (Ocean Nutrition, Halifax, Nova Scotia, Canada) comprising a
total of 3.7 g of n-3 PUFAs with 56.0% as docosahexaenoic acid
(DHA) and 27.7% as eicosapentaenoic acid (EPA), from 20 weeks gestation until birth

Intervention code [1]

Prevention

Comparator / control treatment

The control group received 4 (1-g) capsules
of olive oil per day (containing 66.6% n-9 oleic acid and <1% n-3
PUFAs; Pan Laboratories, Moorebank, NSW, Australia), from 20 weeks gestation until birth

Control group

Placebo

Outcomes

Primary outcome [1]

Effects on neonatal immune function (cytokine responses to various in vitro stimuli): between group comparison. This is assessed by mononuclear cell cultures, cytokine detection (by ELISA and TRF) and flow cytometry.

Timepoint [1]

Birth

Secondary outcome [1]

Allergic symptoms and sensitisation.
This is assessed by clinical history, examination and by allergen skin prick testing.

Timepoint [1]

When infant is 1 year of age.

Eligibility

Key inclusion criteria

Mothers with a history of allergic disease and evidence of sensitisation (positive skin tests), but are otherwise healthy.

Minimum age

18 Years

Maximum age

44 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Any significant pregnancy or neonatal complications.
Preterm delivery
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)

Randomization and allocation of capsules occurred at a different
center separate from the recruitment of participants. Capsules were administered to the participants by someone separate from those doing the allocation. The capsules in the 2 groups were imagematched, and the participants, research scientists, and pediatrician remained blinded to the groups for the duration of the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The groups were block-randomized according to parity (no previous
term childbirth versus 1 or more), prepregnancy body mass
index (BMI), age, and maternal allergy (allergic rhinitis or asthma).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/1999

Actual

1/05/1999

Date of last participant enrolment

Anticipated

Actual

10/10/2001

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council GHD Building Level 1
16 Marcus Clarke St, Canberra, ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Western Australia

Address

35 Stirling Highway
Crawley WA 6009
Western Australia

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Princess Margaret Hospital

Address [1]

Roberts Rd, Subiaco
GPO Box D 184 Perth, WA, 6840
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital Ethics Committee

Ethics committee address [1]

Princess Margaret Hospital for Children
GPO Box D 184 Perth, WA, 6840
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/04/1999

Ethics approval number [1]

358/EP

Summary

Brief summary

Background: There is growing interest in the potential role of
anti-inflammatory n-3 polyunsaturated fatty acids (n-3
PUFAs) in the prevention of allergic disease.
Objective:We sought to determine whether maternal dietary
supplementation with n-3 PUFAs during pregnancy could
modify immune responses in infants.
Methods: In a randomized, controlled trial 98 atopic, pregnant
women received fish oil (3.7 g n-3 PUFAs per day) or placebo
from 20 weeks’ gestation until delivery. Neonatal PUFA levels
and immunologic response to allergens were measured at birth.
Results: Eighty-three women completed the study. Fish oil
supplementation (n = 40) achieved significantly higher proportions of n-3 PUFAs in neonatal erythrocyte membranes (mean ± SD, 17.75% ± 1.85% as a percentage of total fatty acids) compared with the control group (n = 43, 13.69% ± 1.22%, P < .001). All neonatal cytokine (IL-5, IL-13, IL-10, and IFN-g) responses (to all allergens) tended to be lower in the fish oil group (statistically significant only for IL-10 in response to
cat). Although this study was not designed to examine clinical
effects, we noted that infants in the fish oil group were 3 times
less likely to have a positive skin prick test to egg at 1 year of
age (odds ratio, 0.34; 95% confidence interval, 0.11 to 1.02; P
= .055). Although there was no difference in the frequency of
atopic dermatitis at 1 year of age, infants in the fish oil group
also had significantly less severe disease (odds ratio, 0.09; 95%
confidence interval, 0.01 to 0.94; P = .045).
Conclusions: These data suggest a potential reduction in subsequent infant allergy after maternal PUFA supplementation.
More detailed follow-up studies are required in larger cohorts
to establish the robustness of these findings and to ascertain
their significance in relation to longer-term modification of
allergic disease in children.

Trial website

Trial related presentations / publications

Journal  Dunstan et al. Fish oil supplementation in pregnancy modifies neonatal allergen-specific immune responses and clinical outcomes in infants at high risk of atopy: A randomized, controlled trial J Allergy Clin Immunol 2003;112:1178-84.

Public notes

Contacts

Principal investigator

Name

Prof Susan Prescott

Address

Professor and Paediatric Allergist and Immunologist
School of Paediatrics and Child Health
University of Western Australia
Princess Margaret Hospital for Children
GPO Box D 184 Perth, WA, 6840
Australia
tel: +618-9340 -8171
fax: +618 9388 2097
email: [email protected]

Country

Australia

Phone

tel: +618-9340 -8171

Fax

[email protected]

Contact person for public queries

Name

Prof Susan Prescott

Address

Winthrop Professor and Paediatric Allergist and Immunologist
School of Paediatrics and Child Health
University of Western Australia
Princess Margaret Hospital for Children
GPO Box D 184 Perth, WA, 6840
Australia

Country

Australia

Phone

+618-9340 -8171

Fax

+618 9388 2097

[email protected]

Contact person for scientific queries

Name

Prof Susan Prescott

Address

as above

Country

Australia

Phone

+618-9340 -8171

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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