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

Sponsor

Linkoeping University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00892684

Collaborator

Pharma Nord (Industry), The Ekhaga Foundation, Stockholm, Sweden (Other), The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) (Other), Medical Research Council of Southeast Sweden (Other), Ostergotland County Council, Sweden (Other), The Swedish Asthma and Allergy Research Foundation, Stockholm, Sweden. (Other)

146

Enrollment

Location

102

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allergies	Dietary Supplement: Omega-3 long chain polyunsaturated fatty acids Dietary Supplement: Soybean oil (placebo)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Jun 1, 2005

Anticipated Study Completion Date :

Sep 1, 2011

Outcome Measures

Primary Outcome Measures

allergic eczema [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Linkoeping		Sweden	58185

Sponsors and Collaborators

Linkoeping University
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.