Allergies
Conditions
Keywords
Randomized, Placebo controlled, Double blind, Omega-3 fatty acids, Pregnancy, Childhood allergy, Cytokines, Eicosanoids, Polyunsaturated fatty acids
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.
Interventions
DIETARY_SUPPLEMENTOmega-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_SUPPLEMENTSoybean 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
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.
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| allergic eczema | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| changes in laboratory parameters such as prostaglandins and cytokines associated to the intervention and the primary outcome | 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 |
Countries
Sweden
Outcome results
None listed