Overview

This trial is active, not recruiting.

Condition allergies
Treatments omega-3 long chain polyunsaturated fatty acids, soybean oil (placebo)
Sponsor Linkoeping University
Collaborator Pharma Nord
Start date March 2003
End date June 2005
Trial size 146 participants
Trial identifier NCT00892684, FA-013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention

Primary Outcomes

Measure
allergic eczema
time frame: 2 years

Secondary Outcomes

Measure
changes in laboratory parameters such as prostaglandins and cytokines associated to the intervention and the primary outcome
time frame: 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

Female participants of any age.

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

Additional Information

Official title Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation: a Randomized, Double-Blind, Placebo Controlled Trial.
Principal investigator Karel M Duchén, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Linkoeping University.