NCT00892684

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 4, 2009

Status Verified

May 1, 2009

Enrollment Period

2.3 years

First QC Date

May 1, 2009

Last Update Submit

May 1, 2009

Conditions

Allergies

Keywords

RandomizedPlacebo controlledDouble blindOmega-3 fatty acidsPregnancyChildhood allergyCytokinesEicosanoidsPolyunsaturated fatty acids

Outcome Measures

Primary Outcomes (1)

  • allergic eczema

    2 years

Secondary Outcomes (1)

  • 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

Interventions

Omega-3 long chain polyunsaturated fatty acidsDIETARY_SUPPLEMENT

2.7g ω-3 LCPUFA i.e., 1.6 g EPA and 1.1 g DHA and 23 mg alfa-tocopherol as an antioxidant

Also known as: Bio-Marin, Pharma Nord, Denmark
Soybean oil (placebo)DIETARY_SUPPLEMENT

2.8 g soybean oil containing 2.5 g linoleic acid and 0.28 g α-linolenic and 36 mg alfa-tocopherol

Also known as: Placebo, Pharma Nord, Denmark

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Soy allergy
  • Fish allergy
  • Treatment with anti-coagulation
  • Commercial omega-3 supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Soybean Oil

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Karel M Duchén, MD, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 4, 2009

Study Start

March 1, 2003

Primary Completion

June 1, 2005

Study Completion

September 1, 2011

Last Updated

May 4, 2009

Record last verified: 2009-05

Locations

SE(1)