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Fish oil in pregnancy may cut childhood asthma risk, major trial launches

NCT ID NCT06560255

Prevention Sponsor: Professor Klaus Bønnelykke Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether taking high-dose fish oil supplements during pregnancy can prevent asthma and persistent wheezing in early childhood. The trial will enroll 2000 pregnant Danish women with low blood levels of omega-3s. Participants take fish oil or placebo capsules daily from week 22-26 of pregnancy until one week after delivery. The main goal is to see if this reduces the number of children diagnosed with asthma or wheezing by age 3.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
n-3 fatty acid (fish oil)
What this could lead to
If it works, this could offer a simple, personalized way to reduce the risk of asthma and wheezing in early childhood.
What could go wrong
This is a large phase 3 trial, but previous studies on fish oil in pregnancy have had mixed results. The benefit may be small or not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Mar 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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

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Conditions

The condition(s) this trial relates to.

allergic disease asthma atopic eczema bone fracture croup developmental disability digestive system infectious disorder Eczema Infections psychiatric disorder Respiratory Sounds respiratory tract infectious disorder childhood onset asthma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allergy Asthma Cognition disorders in children Croup Development, child Eczema Fractures, bone Gastrointestinal infection Psychiatric diagnosis Respiratory tract infections Wheezing

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Copenhagen University Hospital of Copenhagen

    RECRUITING

    Gentofte Municipality, DK-2820, Denmark

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