We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00892684
Recruitment Status : Unknown
Verified May 2009 by Linkoeping University.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2009
Last Update Posted : May 4, 2009
Sponsor:
Collaborators:
Information provided by:

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

Study Design

Study Type : Interventional  (Clinical Trial)
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 : March 2003
Primary Completion Date : June 2005
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. allergic eczema [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Karel Duchén, Linkoeping University
ClinicalTrials.gov Identifier: NCT00892684     History of Changes
Other Study ID Numbers: FA-013
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: May 4, 2009
Last Verified: May 2009

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