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

NCT00892684 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2009-05-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Pharma Nord

    collaborator INDUSTRY
  • The Ekhaga Foundation, Stockholm, Sweden

    collaborator UNKNOWN
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

    collaborator OTHER_GOV
  • Medical Research Council of Southeast Sweden

    collaborator OTHER_GOV
  • Ostergotland County Council, Sweden

    collaborator OTHER
  • The Swedish Asthma and Allergy Research Foundation, Stockholm, Sweden.

    collaborator UNKNOWN
  • Linkoeping University

    lead OTHER_GOV

Principal Investigators

  • Karel M Duchén, MD, PhD · Linkoeping University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2005-06-30
Completion
2011-09-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892684 on ClinicalTrials.gov