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

Tracking Information

First Received Date ^ICMJE

November 25, 2008

Last Updated Date

June 18, 2012

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00798226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma
Eczema
Allergy

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
n-3 fatty acid

Intervention: Dietary Supplement: n-3 fatty acid
Placebo Comparator: 2
Olive oil

Intervention: Dietary Supplement: olive oil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

March 2014

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00798226

Other Study ID Numbers ^ICMJE

H-B-2008-093

Has Data Monitoring Committee

Responsible Party

Copenhagen Studies on Asthma in Childhood

Study Sponsor ^ICMJE

Copenhagen Studies on Asthma in Childhood

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hans Bisgaard, MD, DMSc

COPSAC / University of Copenhagen

Information Provided By

Copenhagen Studies on Asthma in Childhood

Verification Date

July 2011

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

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