Does Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?

Study Overview
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Brief Summary
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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.

Official Title
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Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation: a Randomized, Double-Blind, Placebo Controlled Trial.

Conditions
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Allergies

Intervention / Treatment
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* Dietary Supplement: Omega-3 long chain polyunsaturated fatty acids
* Dietary Supplement: Soybean oil (placebo)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic eczema |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, Placebo controlled, Double blind, Omega-3 fatty acids, Pregnancy, Childhood allergy, Cytokines, Eicosanoids, Polyunsaturated fatty acids