Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood - Full Text View

Sponsor:	Copenhagen Studies on Asthma in Childhood
Information provided by:	Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier:	NCT00798226

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 III

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

Drug Information available for: Fish oil

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:	November 2013
Estimated Primary Completion Date:	November 2013 (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:	Professor Hans Bisgaard, Health Sciences, University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00798226 History of Changes
Other Study ID Numbers:	H-B-2008-093
Study First Received:	November 25, 2008
Last Updated:	July 11, 2011
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:

Hypersensitivity
Asthma
Eczema
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 February 09, 2012