Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

NCT ID: NCT06560255

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2033-03-31

Brief Summary

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The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development.

Detailed Description

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Randomization of 2000 pregnant women to fish oil of 2.4 g/day (55% EPA and 37% DHA) in triacylglycerol form vs placebo. Supplementation begins in gestational week 24 (22-26) until 1 week after delivery. Allocation to the trial will be determined based on the pre-interventional maternal blood levels of EPA+DHA with a dried blood screening test. Women with low levels (below 4.7% of total fatty acids) will be assigned to the fish oil RCT. Maternal blood will be used for genetic, metabolomic and proteomic profiling. A 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. The primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. Secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. A follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.

Conditions

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Asthma Respiratory Tract Infections Gastrointestinal Infection Croup Eczema Allergy Wheezing Fractures, Bone Development, Child Cognition Disorders in Children Psychiatric Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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n-3 fatty acid of 2.4 g per day

Oral intake of 4 capsules daily from week 22-26 of gestation until 1 week after delivery

Group Type EXPERIMENTAL

n-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Rape seed oil

Oral intake of 4 capsules daily from week 22-26 of gestation until 1 week after delivery

Group Type PLACEBO_COMPARATOR

Rape seed oil

Intervention Type OTHER

Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Interventions

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n-3 fatty acid

Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Intervention Type DIETARY_SUPPLEMENT

Rape seed oil

Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Intervention Type OTHER

Other Intervention Names

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GoldenOmega, PharmaNord, DK Placebo capsules, PharmaNord, DK

Eligibility Criteria

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Inclusion Criteria

* Pregnant Danish women before week 26 with blood levels of EPA+DHA below 4.7% of total fatty acids
* No planned use of fish oil supplementations
* No endocrine-, heart-, kidney- or auto-immune disorders
* No disorders requiring treatment with blood thinning medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Professor Klaus Bønnelykke

OTHER

Sponsor Role lead

Responsible Party

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Professor Klaus Bønnelykke

Professor PhD, Head of COPSAC

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bo Chawes, PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen Studies on Asthma in Childhood

Klaus Bønnelykke, PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen Studies on Asthma in Childhood

Locations

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Copenhagen University Hospital of Copenhagen

Gentofte Municipality, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Klaus Bønnelykke, PhD

Role: CONTACT

+45 38677360

Ulrik Ralfkiaer, PhD

Role: CONTACT

+45 38674164

Facility Contacts

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Klaus Bønnelykke, PhD

Role: primary

+45 38677360

Ulrik Ralfkiaer, PhD

Role: backup

+45 38674164

References

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Brustad N, Vahman N, Ralfkiaer U, Mikkelsen M, Brandt S, Kyvsgaard JN, Vinding R, Stokholm J, Chawes B, Bonnelykke K. Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials. BMJ Open. 2024 Dec 31;14(12):e092902. doi: 10.1136/bmjopen-2024-092902.

Reference Type DERIVED
PMID: 39740942 (View on PubMed)

Other Identifiers

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H-23055833-F

Identifier Type: -

Identifier Source: org_study_id

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