Condition(s) treated: Asthma; Eczema; Allergy

Intervention: n-3 fatty acid (Dietary Supplement); olive oil (Dietary Supplement)

Phase: Phase 3

Enrollment status: Recruiting

Sponsor: Copenhagen Studies on Asthma in Childhood

Principal investigator(s) or official(s):
Hans Bisgaard, MD, MDSc, Principal Investigator, Affiliation: COPSAC / University of Copenhagen

Overall contact:
Hans Bisgaard, MD, DMSc, Phone: +45 39777360, Email: bisgaard@copsac.com

The aim of this study is to prevent asthma and allergies in childhood by supplementation with fish oil (n-3 fatty acids) to the mother during pregnancy.

Paticipants are mother and children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week 24 of gestation to 1 week after delivery. The child is followed with acute and planned visit at the research unit and diagnosis of disease is done in the research unit according to predefined algorithms.

Official title: Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood: Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort.

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:
Development af wheezy disorder from 0 to 3 years of age (Time Frame: 3 years)

Development of eczema from 0 to 3 years of age (Time Frame: 3 years)

Sensitization at 18 months of age (Time Frame: 18 months)

Secondary outcome:
Development of Asthma exacerbations from 0 to 3 years of age (Time Frame: 3 years)

Infections from 0 to 3 years of age (Time Frame: 3)

Minimum eligible age: 18 Years. Eligible gender(s): Female.

Criteria:

Inclusion Criteria (mother):

- Pregnant women

- Living in Sealand, Denmark

- Fluent in Danish Language

- Willing to let the newborn child participate in the study

Exclusion Criteria (mother):

- Participating in other clinical trial

Hans Bisgaard, MD, DMSc, Phone: +45 39777360, Email: bisgaard@copsac.com

Copenhagen University Hospital of Copenhagen, Gentofte 2820, Denmark; Recruiting
Hans Bisgaard, MD, DMSc, Phone: +45 39777360, Email: bisgaard@copsac.com
Klaus Bønnelykke, MD, Phone: +45 31903259, Email: kb@copsac.com
Hans Bisgaard, MD, DMSc, Principal Investigator
Klaus Bønnelykke, MD, Sub-Investigator
Charlotte Giwerchmann, MD, Sub-Investigator

Næstved Hopsital, Pediatric Department, Næstved 4700, Denmark; Recruiting
Porntiva Poorisrisak, MD, Phone: +45 27287639, Email: ppo@regionsjaelland.dk
Porntiva Poorisrisak, MD, Principal Investigator

Start date: November 2008
End date: November 2013
Last updated: November 25, 2008

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