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

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 Bønnelykke. 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 children's 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.

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma