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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier:
NCT00798226
First received: November 25, 2008
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Eczema
Allergy
Dietary Supplement: n-3 fatty acid
Dietary Supplement: olive oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Copenhagen Studies on Asthma in Childhood:

Primary Outcome Measures:
  • Persistent wheeze 0 to 3 years of age [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • Asthma exacerbations [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-3 years of age ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]
    Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria

  • Allergic sensitization [ Time Frame: 6 and 18 months of age ] [ Designated as safety issue: No ]
    Allergic sensitization at 6 and/or 18 months of age assessed by skin prick test and specific IgE in blood

  • Systemic immune status [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 4 weeks and 2 years of age ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 800
Study Start Date: November 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
n-3 fatty acid
Dietary Supplement: n-3 fatty acid
Oral intake of 4 capsules daily from week 24 og gestation to 1 week after delivery
Other Name: Incromega (Croda Nordica AB), Krossverksgatan 5 C, SE-216 16 Limhamn, Sweden
Placebo Comparator: 2
Olive oil
Dietary Supplement: olive oil
Oral intake of 4 capsules (1 g) daily from 26 weeks of gestation to 1 week after delivery
Other Name: Pharmatech AS, Po 85, 1662 Rolvsøy, Norway

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798226

Locations
Denmark
Copenhagen University Hospital of Copenhagen
Gentofte, Denmark, 2820
Næstved Hospital, Pediatric Department
Næstved, Denmark, 4700
Sponsors and Collaborators
Copenhagen Studies on Asthma in Childhood
Investigators
Principal Investigator: Hans Bisgaard, MD, DMSc COPSAC / University of Copenhagen
  More Information

No publications provided

Responsible Party: Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier: NCT00798226     History of Changes
Other Study ID Numbers: H-B-2008-093
Study First Received: November 25, 2008
Last Updated: February 25, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen Studies on Asthma in Childhood:
Asthma
Eczema
Sensitization
Allergy

Additional relevant MeSH terms:
Eczema
Hypersensitivity
Asthma
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Dermatitis
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on August 20, 2014