Fish oil supplementation during pregnancy to prevent asthma in children
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma (FREYA)
This study is testing if taking high-dose fish oil during pregnancy can help reduce the chances of children developing asthma and breathing problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Copenhagen Studies on Asthma in Childhood Academic / other |
| Locations | 1 site (Gentofte Municipality) |
| Trial ID | NCT06560255 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of high-dose fish oil supplementation during pregnancy in reducing the risk of early childhood asthma and related respiratory issues. Pregnant women with low levels of EPA and DHA will be randomly assigned to receive either fish oil or a placebo starting at 24 weeks of gestation until one week after delivery. The study will track the health outcomes of their children for three years, focusing on asthma, respiratory infections, and other related conditions. Maternal blood samples will also be analyzed for genetic and metabolic factors that may influence outcomes.
Who should consider this trial
Good fit: Ideal candidates are pregnant women in Denmark before 26 weeks of gestation with low EPA+DHA levels.
Not a fit: Patients with planned fish oil supplementation or those with certain health disorders like endocrine, heart, kidney, or autoimmune conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of asthma and related respiratory conditions in children.
How similar studies have performed: Other studies have explored the role of omega-3 fatty acids in pregnancy, but this specific high-dose approach is relatively novel.
Eligibility criteria
Show full inclusion / 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 * No disorders requiring treatment with blood thinning medication
Where this trial is running
Gentofte Municipality
- Copenhagen University Hospital of Copenhagen — Gentofte Municipality, Denmark (Recruiting)
Study contacts
- Principal investigator: Bo Chawes, PhD — Copenhagen Studies on Asthma in Childhood
- Study coordinator: Klaus Bønnelykke, PhD
- Email: kb@copsac.com
- Phone: +45 38677360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.