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

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

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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