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Phase 3
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06560255

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

Led by Professor Klaus Bønnelykke · Updated on 2025-09-30

2000

Participants Needed

1

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether taking fish oil supplements during pregnancy can help prevent early childhood asthma and persistent wheeze within the first three years of life. The study focuses on pregnant women with low levels of certain fatty acids in their blood and aims to see if higher doses than currently recommended may reduce the risk of developing these respiratory conditions. This is a Phase 3 randomized clinical trial led by Professor Klaus Bnnelykke. The study involves 2000 pregnant women who will be randomly assigned to receive either fish oil capsules containing 2.4 grams per day of specific fatty acids EPA and DHA or placebo capsules of rapeseed oil. Supplementation starts between the 22nd and 26th week of pregnancy and continues until one week after delivery. Participants blood will be analyzed for genetic and metabolic markers at baseline, and children will be followed for three years after birth with ongoing monitoring planned up to six years of age. During the study, parents will report their childrens symptoms, diagnoses, medication use, and hospital visits related to asthma, wheeze, infections, allergies, development, and mental health. Researchers will assess outcomes such as persistent wheeze or asthma by age three and evaluate other health issues including lung infections, eczema, allergies, cognitive development, and growth. The study includes thorough monitoring of both primary and secondary health outcomes through follow-ups and medical record reviews over several years.

CONDITIONS

Brief Title

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

Research Team

K

Klaus Bønnelykke, PhD

U

Ulrik Ralfkiaer, PhD

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