ClinicalTrials.Veeva

Menu

Fish Oil in PREgnancY for Personalized Prevention of Early Childhood Asthma (FREYA)

P

Professor Klaus Bønnelykke

Status and phase

Enrolling
Phase 3

Conditions

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

Treatments

Dietary Supplement: n-3 fatty acid
Other: Rape seed oil

Study type

Interventional

Funder types

Other

Identifiers

NCT06560255
H-23055833-F

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,000 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2,000 participants in 2 patient groups, including a placebo group

n-3 fatty acid of 2.4 g per day
Experimental group
Description:
Oral intake of 4 capsules daily from week 22-26 of gestation until 1 week after delivery
Treatment:
Dietary Supplement: n-3 fatty acid
Rape seed oil
Placebo Comparator group
Description:
Oral intake of 4 capsules daily from week 22-26 of gestation until 1 week after delivery
Treatment:
Other: Rape seed oil

Trial contacts and locations

1

Loading...

Central trial contact

Klaus Bønnelykke, PhD; Ulrik Ralfkiaer, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems