Allergy, Asthma, Eczema
Conditions
Keywords
Asthma, Eczema, Sensitization, Allergy
Brief 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.
Interventions
DIETARY_SUPPLEMENTn-3 fatty acid
Oral intake of 4 capsules daily from week 24 of gestation to 1 week after delivery
DIETARY_SUPPLEMENTolive oil
Oral intake of 4 capsules (1 g) daily from 24 weeks of gestation to 1 week after delivery
Sponsors
Copenhagen Studies on Asthma in Childhood
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent wheeze 0 to 3 years of age | 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma exacerbations | 0-3 years | 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 |
| Infections | 0-3 years of age | 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 |
| Growth | 0 to 3 years of age | * 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 |
| Neurological development | 0-3 years | 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) |
| Eczema | 0-3 years | Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria |
| Allergic sensitization | 6 and 18 months of age | Allergic sensitization at 6 and/or 18 months of age assessed by skin prick test and specific IgE in blood |
| Systemic immune status | 18 months | 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 |
| Airway mucosal immune status | 4 weeks and 2 years of age | 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) |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORKlaus Bønnelykke, MD, PhD
COPSAC / University of Copenhagen
Outcome results
None listed