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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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] 253377 0
PMH 358/EP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy 260928 0
Condition category
Condition code
Inflammatory and Immune System 259061 259061 0 0
Reproductive Health and Childbirth 259080 259080 0 0
Normal pregnancy
Alternative and Complementary Medicine 259081 259081 0 0
Other alternative and complementary medicine

Study type
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] 257823 0
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

Primary outcome [1] 259915 0
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] 259915 0
Secondary outcome [1] 268812 0
Allergic symptoms and sensitisation.
This is assessed by clinical history, examination and by allergen skin prick testing.
Timepoint [1] 268812 0
When infant is 1 year of age.

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
Can healthy volunteers participate?
Key exclusion criteria
Any significant pregnancy or neonatal complications.
Preterm delivery

Study design
Purpose of the study
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258295 0
Government body
Name [1] 258295 0
Address [1] 258295 0
National Health and Medical Research Council GHD Building Level 1
16 Marcus Clarke St, Canberra, ACT 2601
Country [1] 258295 0
Primary sponsor type
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Western Australia
Secondary sponsor category [1] 257458 0
Name [1] 257458 0
Princess Margaret Hospital
Address [1] 257458 0
Roberts Rd, Subiaco
GPO Box D 184 Perth, WA, 6840
Country [1] 257458 0

Ethics approval
Ethics application status
Ethics committee name [1] 260280 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 260280 0
Princess Margaret Hospital for Children
GPO Box D 184 Perth, WA, 6840
Ethics committee country [1] 260280 0
Date submitted for ethics approval [1] 260280 0
Approval date [1] 260280 0
Ethics approval number [1] 260280 0

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

Principal investigator
Name 32073 0
Prof Susan Prescott
Address 32073 0
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
tel: +618-9340 -8171
fax: +618 9388 2097
Country 32073 0
Phone 32073 0
tel: +618-9340 -8171
Fax 32073 0
Email 32073 0
Contact person for public queries
Name 15320 0
Prof Prof Susan Prescott
Address 15320 0
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
Country 15320 0
Phone 15320 0
+618-9340 -8171
Fax 15320 0
+618 9388 2097
Email 15320 0
Contact person for scientific queries
Name 6248 0
Prof Prof Susan Prescott
Address 6248 0
as above
Country 6248 0
Phone 6248 0
+618-9340 -8171
Fax 6248 0
Email 6248 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary