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

November 25, 2008
February 25, 2014
November 2008
April 2014   (final data collection date for primary outcome measure)
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
  • Development of eczema from 0 to 3 years of age [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Development af wheezy disorder from 0 to 3 years of age [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Sensitization at 18 months of age [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00798226 on ClinicalTrials.gov Archive Site
  • 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)
  • Development of Asthma exacerbations from 0 to 3 years of age [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Infections from 0 to 3 years of age [ Time Frame: 3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Asthma
  • Eczema
  • Allergy
  • 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
  • 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
  • Active Comparator: 1
    n-3 fatty acid
    Intervention: Dietary Supplement: n-3 fatty acid
  • Placebo Comparator: 2
    Olive oil
    Intervention: Dietary Supplement: olive oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00798226
H-B-2008-093
No
Copenhagen Studies on Asthma in Childhood
Copenhagen Studies on Asthma in Childhood
Not Provided
Principal Investigator: Hans Bisgaard, MD, DMSc COPSAC / University of Copenhagen
Copenhagen Studies on Asthma in Childhood
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP