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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Linkoeping University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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.
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT00892684
First received: May 1, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • allergic eczema [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 146
Study Start Date: March 2003
Estimated Study Completion Date: September 2011
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: Bio-Marin, Pharma Nord, Denmark
    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
    Other Name: Placebo, Pharma Nord, Denmark
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892684

Locations
Sweden
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.
Investigators
Principal Investigator: Karel M Duchén, MD, PhD Linkoeping University
  More Information

No publications provided

Responsible Party: Karel Duchén, Linkoeping University
ClinicalTrials.gov Identifier: NCT00892684     History of Changes
Other Study ID Numbers: FA-013
Study First Received: May 1, 2009
Last Updated: May 1, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Randomized
Placebo controlled
Double blind
Omega-3 fatty acids
Pregnancy
Childhood allergy
Cytokines
Eicosanoids
Polyunsaturated fatty acids

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014