Status:

RECRUITING

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

Lead Sponsor:

Professor Klaus Bønnelykke

Conditions:

Asthma

Respiratory Tract Infections

Eligibility:

FEMALE

18-45 years

Phase:

PHASE3

Brief Summary

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 ...

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 deliver...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 20 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2033

    Estimated Enrollment :

    2000 Patients enrolled

    Trial Details

    Trial ID

    NCT06560255

    Start Date

    December 20 2024

    End Date

    March 1 2033

    Last Update

    September 30 2025

    Active Locations (1)

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    1

    Copenhagen University Hospital of Copenhagen

    Gentofte Municipality, Denmark, DK-2820