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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
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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
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Secondary ID [1]
253377
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PMH 358/EP
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Universal Trial Number (UTN)
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Trial acronym
APP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Allergy
260928
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Condition category
Condition code
Inflammatory and Immune System
259061
259061
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0
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Allergies
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Reproductive Health and Childbirth
259080
259080
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0
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Normal pregnancy
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Alternative and Complementary Medicine
259081
259081
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
257823
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Prevention
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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
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Control group
Placebo
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Outcomes
Primary outcome [1]
259915
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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.
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Assessment method [1]
259915
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Timepoint [1]
259915
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Birth
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Secondary outcome [1]
268812
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Allergic symptoms and sensitisation.
This is assessed by clinical history, examination and by allergen skin prick testing.
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Assessment method [1]
268812
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Timepoint [1]
268812
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When infant is 1 year of age.
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Eligibility
Key inclusion criteria
Mothers with a history of allergic disease and evidence of sensitisation (positive skin tests), but are otherwise healthy.
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Minimum age
18
Years
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Maximum age
44
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Any significant pregnancy or neonatal complications.
Preterm delivery
Smoking
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/1999
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Actual
1/05/1999
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Date of last participant enrolment
Anticipated
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Actual
10/10/2001
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
258295
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Government body
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Name [1]
258295
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NHMRC
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Address [1]
258295
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National Health and Medical Research Council GHD Building Level 1
16 Marcus Clarke St, Canberra, ACT 2601
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Country [1]
258295
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Australia
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Primary sponsor type
University
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Name
University of Western Australia
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Address
35 Stirling Highway
Crawley WA 6009
Western Australia
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Country
Australia
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Secondary sponsor category [1]
257458
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Hospital
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Name [1]
257458
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Princess Margaret Hospital
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Address [1]
257458
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Roberts Rd, Subiaco
GPO Box D 184 Perth, WA, 6840
Australia
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Country [1]
257458
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260280
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Princess Margaret Hospital Ethics Committee
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Ethics committee address [1]
260280
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Princess Margaret Hospital for Children
GPO Box D 184 Perth, WA, 6840
Australia
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Ethics committee country [1]
260280
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Australia
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Date submitted for ethics approval [1]
260280
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Approval date [1]
260280
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15/04/1999
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Ethics approval number [1]
260280
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358/EP
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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.
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Trial website
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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.
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Public notes
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Contacts
Principal investigator
Name
32073
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Prof Susan Prescott
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Address
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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]
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Country
32073
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Australia
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Phone
32073
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tel: +618-9340 -8171
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Fax
32073
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Prof Susan Prescott
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Address
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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
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Country
15320
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Australia
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Phone
15320
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+618-9340 -8171
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Fax
15320
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+618 9388 2097
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Email
15320
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[email protected]
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Contact person for scientific queries
Name
6248
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Prof Prof Susan Prescott
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Address
6248
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as above
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Country
6248
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Australia
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Phone
6248
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+618-9340 -8171
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Fax
6248
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Email
6248
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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