Does Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?
NCT00892684 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146
Last updated 2009-05-04
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Omega-3 long chain polyunsaturated fatty acids
2.7g ω-3 LCPUFA i.e., 1.6 g EPA and 1.1 g DHA and 23 mg alfa-tocopherol as an antioxidant
- DIETARY_SUPPLEMENT
-
Soybean oil (placebo)
2.8 g soybean oil containing 2.5 g linoleic acid and 0.28 g α-linolenic and 36 mg alfa-tocopherol
Sponsors & Collaborators
-
Pharma Nord
collaborator INDUSTRY -
The Ekhaga Foundation, Stockholm, Sweden
collaborator UNKNOWN -
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
collaborator OTHER_GOV -
Medical Research Council of Southeast Sweden
collaborator OTHER_GOV -
Ostergotland County Council, Sweden
collaborator OTHER -
The Swedish Asthma and Allergy Research Foundation, Stockholm, Sweden.
collaborator UNKNOWN -
Linkoeping University
lead OTHER_GOV
Principal Investigators
-
Karel M Duchén, MD, PhD · Linkoeping University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2005-06-30
- Completion
- 2011-09-30
Countries
- Sweden
Study Locations
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