Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorProfessor Klaus Bønnelykke

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • n-3 fatty acid

    Dietary supplement

    Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

  • Rape seed oil

    Other intervention

    Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: n-3 fatty acid of 2.4 g per dayExperimental treatment 1 intervention
Group B: Rape seed oilPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Early childhood asthma/persistent wheeze age 0-3 years

Defined as either a) parental report of a minimum of 2 wheeze episodes with at least 1 after the child's second birthday and redemption of at least 2 prescriptions of asthma controller medication with at least 1 being after the child's second birthday or b) a minimum of 2 ED visits or hospitalizations due to asthmatic symptoms, and at least 1 of these being after the child's second birthday or c) parental report of physician-diagnosed asthma age 0-3 years Outcome analysis: risk (survival analysis) of persistent wheeze or asthma at age 0-3 years.

Time frame
3 years

Secondary outcomes

1

Atopic/non-atopic wheeze or asthma age 0-3 years

Parental reports of physician diagnosed asthma in combination with eczema and/or allergic rhinitis. Outcome analyses: asthma/persistent wheeze with/without eczema and/or allergic rhinitis (yes/no) by age 3 years. Each subtype is compared with children without asthma.

Time frame
3 years
2

Troublesome lung symptoms age 0-3 years

Defined as cough, wheeze or dyspnea severely affecting the well-being of the child for at least 3 consecutive days based on parental reports. Outcome analyses: total no. of episodes with symptoms age 0-3 years.

Time frame
3 years
3

Wheeze episodes age 0-3 years

Parental reports of wheezing. Outcome analyses: total no. of episodes with wheeze age 0-3 years.

Time frame
3 years
4

Inhaled bronchodilator use from parental reports age 0-3 years

Outcome analyses: total no. of days with bronchodilator use age 0-3.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Professor Klaus Bønnelykke

Lead sponsor

Copenhagen Studies on Asthma in Childhood

Sponsor institution