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

Phase 1

Active, not recruiting

• Conditions: Eczema; Asthma; Allergy
• Interventions: Dietary Supplement: olive oil; Dietary Supplement: n-3 fatty acid

• Registration Number: NCT00798226
• Lead Sponsor: Copenhagen Studies on Asthma in Childhood

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study Start: 2008-11-26
• Study First Posted: 2008-11-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	olive oil	Olive oil
1	n-3 fatty acid	n-3 fatty acid

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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)
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
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
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

Trial Locations

Locations (2)

Copenhagen University Hospital of Copenhagen; 🇩🇰 Gentofte, Denmark

Næstved Hospital, Pediatric Department; 🇩🇰 Næstved, Denmark