Overview

This trial is active, not recruiting.

Conditions asthma, eczema, allergy
Treatments n-3 fatty acid, olive oil
Phase phase 3
Sponsor Copenhagen Studies on Asthma in Childhood
Start date November 2008
End date April 2016
Trial size 800 participants
Trial identifier NCT00798226, H-B-2008-093

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
n-3 fatty acid
n-3 fatty acid Incromega (Croda Nordica AB), Krossverksgatan 5 C, SE-216 16 Limhamn, Sweden
Oral intake of 4 capsules daily from week 24 og gestation to 1 week after delivery
(Placebo Comparator)
Olive oil
olive oil Pharmatech AS, Po 85, 1662 Rolvsøy, Norway
Oral intake of 4 capsules (1 g) daily from 26 weeks of gestation to 1 week after delivery

Primary Outcomes

Measure
Persistent wheeze 0 to 3 years of age
time frame: 3 years

Secondary Outcomes

Measure
Asthma exacerbations
time frame: 0-3 years
Infections
time frame: 0-3 years of age
Growth
time frame: 0 to 3 years of age
Neurological development
time frame: 0-3 years
Eczema
time frame: 0-3 years
Allergic sensitization
time frame: 6 and 18 months of age
Systemic immune status
time frame: 18 months
Airway mucosal immune status
time frame: 4 weeks and 2 years of age

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood: Interventional Trial in the COPSAC2010 (Copenhagen Studies on Asthma in Childhood) Birth Cohort
Principal investigator Hans Bisgaard, MD, DMSc
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Copenhagen Studies on Asthma in Childhood.