NCT06560255

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Professor Klaus Bønnelykke · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	n-3 fatty acid	Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery
OTHER	Rape seed oil	Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-10-01
• Completion: 2033-03-01
• First posted: 2024-08-19
• Last updated: 2025-09-30

Locations

1 site across 1 country: Denmark