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

Allergies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00892684
• Other study ID #: FA-013
• Status: Unknown status
• Phase: N/A
• First received: May 1, 2009
• Last updated: May 1, 2009
• Start date: March 2003
• Est. completion date: September 2011

Study information

• Verified date: May 2009
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 146
• Est. completion date: September 2011
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Allergies

Intervention

Dietary Supplement:
• Omega-3 long chain polyunsaturated fatty acids
2.7g ?-3 LCPUFA i.e., 1.6 g EPA and 1.1 g DHA and 23 mg alfa-tocopherol as an antioxidant
• Soybean oil (placebo)
2.8 g soybean oil containing 2.5 g linoleic acid and 0.28 g a-linolenic and 36 mg alfa-tocopherol

Locations

Country	Name	City	State
Sweden	University Hospital	Linkoeping

Sponsors (7)

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

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	allergic eczema		2 years
Secondary	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