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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
800
Oral intake of 4 capsules daily from week 24 of gestation to 1 week after delivery
Oral intake of 4 capsules (1 g) daily from 24 weeks of gestation to 1 week after delivery
Copenhagen University Hospital of Copenhagen
Gentofte Municipality, Gentofte, Denmark
Næstved Hospital, Pediatric Department
Næstved, Næstved, Denmark
Persistent wheeze 0 to 3 years of age
Age at onset of persistent wheeze diagnosed according to predefined algorithm of recurrent troublesome lung symptoms, response to treatment and relapse after withdrawal of treatment
Time frame: 3 years
Asthma exacerbations
Age at onset of severe asthma exacerbation diagnosed by predefined criteria of acute severe asthma requiring oral/high dose inhaled steroids or acute hospital contact
Time frame: 0-3 years
Infections
Main analysis: • Number of lower respiratory tract infections registered in daily diaries Secondary analyses: * Acute otitis media * Number of upper respiratory tract infections * Number of other infections * Total number of infections
Time frame: 0-3 years of age
Growth
* Body composition (fat mass and bone mineral density) assessed by DEXA scan at 3 years of age * Development of BMI from birth to 3 years assesses longitudinally in the research clinic
Time frame: 0 to 3 years of age
Neurological development
Main analysis: • Cognitive development assessed at 2½ years using the cognitive part of Bayley Scales of Infant and Toddler Development, third edition Secondary analyses: * Milestone development monitored prospectively by the parents using a registration form based on The Denver Development Index and WHO milestones registration (combined assessment by principal component analysis) * Language development assessed at 1 and 2 years of age with the Danish version of The MacArthur Bates Communicative Developmental Inventory (CDI) * The child´s general development (language, fine and gross motor, social and problem solving) at 3 years of age assessed with Ages and stages Questioner, third edition (ASQ-3)
Time frame: 0-3 years
Eczema
Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria
Time frame: 0-3 years
Allergic sensitization
Allergic sensitization at 6 and/or 18 months of age assessed by skin prick test and specific IgE in blood
Time frame: 6 and 18 months of age
Systemic immune status
Main analysis * Immune status at 18 months measured in stimulated whole blood as cytokine release (combined assessments by prinicipal component analyses) Secondary analyses * Composition of immune cell subsets in whole blood at birth and at 18 months of age
Time frame: 18 months
Airway mucosal immune status
Immune status measured in airway mucosal lining fluid at 4 weeks and 2 years of age (combined assessments by prinicipal component analyses for each age point)
Time frame: 4 weeks and 2 years of age
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