AllergiesNCT00892684
Does Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?
A study testing Omega-3 long chain polyunsaturated fatty acids in people with Allergies, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Allergies
- What is being tested?
- Omega-3 long chain polyunsaturated fatty acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2003to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Soy allergy
- Fish allergy
- Treatment with anti-coagulation
- Commercial omega-3 supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation: a Randomized, Double-Blind, Placebo Controlled Trial.
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
- Allergies
- Being tested
- Omega-3 long chain polyunsaturated fatty acids, Soybean oil (placebo)
- Keywords
- Randomized, Placebo controlled, Double blind, Omega-3 fatty acids, Pregnancy, Childhood allergy, Cytokines, Eicosanoids, Polyunsaturated fatty acids
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 long chain polyunsaturated fatty acidsDietary supplement
Also called Bio-Marin, Pharma Nord, Denmark
2.7g ω-3 LCPUFA i.e., 1.6 g EPA and 1.1 g DHA and 23 mg alfa-tocopherol as an antioxidant
Soybean oil (placebo)Dietary supplement
Also called Placebo, Pharma Nord, Denmark
2.8 g soybean oil containing 2.5 g linoleic acid and 0.28 g α-linolenic and 36 mg alfa-tocopherol
What is being measured
The primary outcome is the main question the study is designed to answer.
allergic eczema
Measured: 2 years
Secondary outcomes (1)
changes in laboratory parameters such as prostaglandins and cytokines associated to the intervention and the primary outcome
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startMar 2003
- Primary completionJun 2005
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergiesStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- 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.
- Investigators
- Karel M Duchén, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892684
- Sponsor's protocol ID
- FA-013
- Status last verified
- May 2009
- First submitted
- 1 May 2009
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation: a Randomized, Double-Blind, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT00892684
- Acronym / sponsor ID
- FA-013
- Conditions
- Allergies
- Keywords
- Randomized, Placebo controlled, Double blind, Omega-3 fatty acids, Pregnancy, Childhood allergy, Cytokines, Eicosanoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- 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.
- Study start
- Mar 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Soy allergy
- Fish allergy
- Treatment with anti-coagulation
- Commercial omega-3 supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 long chain polyunsaturated fatty acidsAlso: Bio-Marin, Pharma Nord, Denmark2.7g 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)Also: Placebo, Pharma Nord, Denmark2.8 g soybean oil containing 2.5 g linoleic acid and 0.28 g α-linolenic and 36 mg alfa-tocopherol | Dietary supplement | – |
Primary outcome
allergic eczema
Time frame: 2 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel M Duchén, MD, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 long chain polyunsaturated fatty acids in people with Allergies, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
allergic eczema (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2009.