Back to resultsDoes Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?
Primary Purpose
Allergies
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Omega-3 long chain polyunsaturated fatty acids
Soybean oil (placebo)
Sponsored by
About this trial
This is an interventional prevention trial for Allergies focused on measuring Randomized, Placebo controlled, Double blind, Omega-3 fatty acids, Pregnancy, Childhood allergy, Cytokines, Eicosanoids, Polyunsaturated fatty acids
Eligibility Criteria
Inclusion Criteria:
- Pregnant woman, at 25 weeks of gestation, with allergic symptoms (rhinitis, conjunctivitis, eczema, asthma or food allergy) herself or the father to be or an older sibling
Exclusion Criteria:
- Soy allergy
- Fish allergy
- Treatment with anti-coagulation
- Commercial omega-3 supplementation
Sites / Locations
- University Hospital
Outcomes
Primary Outcome Measures
allergic eczema
Secondary Outcome Measures
changes in laboratory parameters such as prostaglandins and cytokines associated to the intervention and the primary outcome
Full Information
NCT ID
NCT00892684
First Posted
May 1, 2009
Last Updated
May 1, 2009
Sponsor
Linkoeping University
Collaborators
Pharma Nord, The Ekhaga Foundation, Stockholm, Sweden, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Medical Research Council of Southeast Sweden, Ostergotland County Council, Sweden, The Swedish Asthma and Allergy Research Foundation, Stockholm, Sweden.
1. Study Identification
Unique Protocol Identification Number
NCT00892684
Brief Title
Does Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?
Official Title
Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation: a Randomized, Double-Blind, Placebo Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Linkoeping University
Collaborators
Pharma Nord, The Ekhaga Foundation, Stockholm, Sweden, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Medical Research Council of Southeast Sweden, Ostergotland County Council, Sweden, The Swedish Asthma and Allergy Research Foundation, Stockholm, Sweden.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The incidence of allergic diseases has increased and a relation between allergy and dietary fatty acids has been proposed. Modulation of the maternal immune function during pregnancy may have an impact on future clinical outcomes in the child. The aim of this study was to determine the effects of omega (ω) - 3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation during pregnancy and lactation on the development of allergic disease (i.e., allergic eczema) in the child at 2 years of age. Pregnant women with allergic disease in their immediate family were supplemented daily with 2.7 g ω-3 LCPUFA (n=70) or 2.8 g soybean-oil as placebo (n=75) from gestational week (gw) 25 until the third month of breastfeeding. Skin prick tests, detection of circulating specific IgE antibodies and clinical examinations of the infants were performed at 3, 6, 12 and 24 months of age. The mothers and children were monitored regarding immune modulatory effects during the entire study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergies
Keywords
Randomized, Placebo controlled, Double blind, Omega-3 fatty acids, Pregnancy, Childhood allergy, Cytokines, Eicosanoids, Polyunsaturated fatty acids
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 long chain polyunsaturated fatty acids
Other Intervention Name(s)
Bio-Marin, Pharma Nord, Denmark
Intervention Description
2.7g ω-3 LCPUFA i.e., 1.6 g EPA and 1.1 g DHA and 23 mg alfa-tocopherol as an antioxidant
Intervention Type
Dietary Supplement
Intervention Name(s)
Soybean oil (placebo)
Other Intervention Name(s)
Placebo, Pharma Nord, Denmark
Intervention Description
2.8 g soybean oil containing 2.5 g linoleic acid and 0.28 g α-linolenic and 36 mg alfa-tocopherol
Primary Outcome Measure Information:
Title
allergic eczema
Time Frame
2 years
Secondary Outcome Measure Information:
Title
changes in laboratory parameters such as prostaglandins and cytokines associated to the intervention and the primary outcome
Time Frame
25th gestational week, at partus and 12 months after partus for the mothers, in cord blood at 3, 12 and 24 months for the children
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant woman, at 25 weeks of gestation, with allergic symptoms (rhinitis, conjunctivitis, eczema, asthma or food allergy) herself or the father to be or an older sibling
Exclusion Criteria:
Soy allergy
Fish allergy
Treatment with anti-coagulation
Commercial omega-3 supplementation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel M Duchén, MD, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Linkoeping
ZIP/Postal Code
58185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Does Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?
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