Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood

Study Overview
=================
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.

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

Conditions
-----------------
Asthma, Eczema, Allergy

Intervention / Treatment
-----------------
* Dietary Supplement: n-3 fatty acid
* Dietary Supplement: olive oil


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>n-3 fatty acid | Dietary Supplement: n-3 fatty acid<br>* Oral intake of 4 capsules daily from week 24 of gestation to 1 week after delivery<br>* Other names: Incromega (Croda Nordica AB), Krossverksgatan 5 C, SE-216 16 Limhamn, Sweden;|
| Placebo Comparator: 2<br>Olive oil | Dietary Supplement: olive oil<br>* Oral intake of 4 capsules (1 g) daily from 24 weeks of gestation to 1 week after delivery<br>* Other names: Pharmatech AS, Po 85, 1662 Rolvsøy, Norway;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | 0-3 years | 
| Eczema | Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria | 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 | 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 | 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) | 4 weeks and 2 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Eczema, Sensitization, Allergy