Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: n-3 fatty acid, Rape seed oil.
- Who it may be relevant to
- Registry conditions: Asthma, Respiratory Tract Infections, Gastrointestinal Infection, Croup. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma (FREYA)
Overview
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.
Interventions
- 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
Primary outcome measures
- Early childhood asthma/persistent wheeze age 0-3 years [Time frame: 3 years]
Secondary outcome measures (12)
- Atopic/non-atopic wheeze or asthma age 0-3 years [Time frame: 3 years]
- Troublesome lung symptoms age 0-3 years [Time frame: 3 years]
- Wheeze episodes age 0-3 years [Time frame: 3 years]
- Inhaled bronchodilator use from parental reports age 0-3 years [Time frame: 3 years]
- Inhaled bronchodilator prescriptions from medical record checks age 0-3 years [Time frame: 3 years]
- Asthma controller medication use from parental reports age 0-3 years [Time frame: 3 years]
- Asthma controller medication prescriptions from medical record checks age 0-3 years [Time frame: 3 years]
- Asthma hospitalizations or emergency department visits age 0-3 years [Time frame: 3 years]
- Eczema age 0-3 years [Time frame: 3 years]
- Allergic rhinitis age 0-3 years [Time frame: 3 years]
- Food allergy 0-3 years [Time frame: 3 years]
- Lower respiratory tract infections age 0-3 years [Time frame: 3 years]
Eligibility 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
- No disorders requiring treatment with blood thinning medication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Copenhagen University Hospital of Copenhagen — Gentofte Municipality
Publications
- Brustad N, Vahman N, Ralfkiaer U, Mikkelsen M, Brandt S, Kyvsgaard JN, Vinding R, Stokholm J, Chawes B, Bonnelykke K. Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials. BMJ Open. 2024 Dec 31;14(12):e092902. doi: 10.1136/bmjopen-2024-092902. PMID 39740942
Identifiers
NCT: NCT06560255 · H-23055833-F