Trial Review

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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] 253377 0
PMH 358/EP
Universal Trial Number (UTN)
Trial acronym
APP
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
Allergies
Reproductive Health and Childbirth 259080 259080 0 0
Normal pregnancy
Alternative and Complementary Medicine 259081 259081 0 0
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] 257823 0
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] 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
Birth
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.

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?
No
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
80
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258295 0
Government body
Name [1] 258295 0
NHMRC
Country [1] 258295 0
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] 257458 0
Hospital
Name [1] 257458 0
Princess Margaret Hospital
Address [1] 257458 0
Roberts Rd, Subiaco
GPO Box D 184 Perth, WA, 6840
Australia
Country [1] 257458 0
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Ethics committee country [1] 260280 0
Australia
Date submitted for ethics approval [1] 260280 0
Approval date [1] 260280 0
15/04/1999
Ethics approval number [1] 260280 0
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 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
Australia
tel: +618-9340 -8171
fax: +618 9388 2097
email: [email protected]
Country 32073 0
Australia
Phone 32073 0
tel: +618-9340 -8171
Fax 32073 0
Email 32073 0
[email protected]
Contact person for public queries
Name 15320 0
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
Australia
Country 15320 0
Australia
Phone 15320 0
+618-9340 -8171
Fax 15320 0
+618 9388 2097
Email 15320 0
[email protected]
Contact person for scientific queries
Name 6248 0
Prof Susan Prescott
Address 6248 0
as above
Country 6248 0
Australia
Phone 6248 0
+618-9340 -8171
Fax 6248 0
Email 6248 0
[email protected]

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