Text Size

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: June 18, 2012
Last verified: July 2011
History of Changes
  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:

MedlinePlus related topics: Allergy Asthma Eczema
U.S. FDA Resources

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

Primary Outcome Measures:
  • Development af wheezy disorder from 0 to 3 years of age [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Development of eczema 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Growth [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
  • Cognitive, language and motor development [ Time Frame: 2½ years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 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
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: June 18, 2012
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 May 19, 2013