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AsthmaPhase 1NCT00798226

Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood

A Phase 1 study testing n-3 fatty acid and olive oil in people with Asthma and Eczema, run by Copenhagen Studies on Asthma in Childhood at 2 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to prevent asthma and allergies in childhood by supplementation with fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and children participating in the ABC-(Asthma Begins in Childhood)cohort. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Asthma, Eczema, Allergy
What is being tested?
n-3 fatty acid and olive oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
2 sitesDenmark
Study dates
26 Nov 2008to Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pregnant women
  • Living in Sealand, Denmark
  • Fluent in Danish Language
  • Willing to let the newborn child participate in the study

Who cannot join

  • Participating in other clinical trial

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Copenhagen University Hospital of Copenhagen

    Gentofte Municipality, Gentofte, 2820

  • Næstved Hospital, Pediatric Department

    Næstved, Næstved, 4700

Other trials in Denmark

About this study

Official title: Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood: Interventional Trial in the COPSAC2010 (Copenhagen Studies on Asthma in Childhood) Birth Cohort

The aim of this study is to prevent asthma and allergies in childhood by supplementation with fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week 24 of gestation to 1 week after delivery. The child is followed with acute and planned visit at the research unit and diagnosis of disease is done in the research unit according to predefined algorithms.

Conditions
Asthma, Eczema, Allergy
Being tested
n-3 fatty acid, olive oil
Keywords
Asthma, Eczema, Sensitization, Allergy
Medical subject headings
Asthma, Eczema, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • n-3 fatty acidDietary supplement

    Also called Incromega (Croda Nordica AB), Krossverksgatan 5 C, SE-216 16 Limhamn, Sweden

    Oral intake of 4 capsules daily from week 24 of gestation to 1 week after delivery

  • olive oilDietary supplement

    Also called Pharmatech AS, Po 85, 1662 Rolvsøy, Norway

    Oral intake of 4 capsules (1 g) daily from 24 weeks of gestation to 1 week after delivery

Study groups in NCT00798226
Study groupRoleWhat they receive
1Active comparatorn-3 fatty acid
Receives: Dietary Supplement: n-3 fatty acid
2Placebo comparatorOlive oil
Receives: Dietary Supplement: olive oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Persistent wheeze 0 to 3 years of age

    Age at onset of persistent wheeze diagnosed according to predefined algorithm of recurrent troublesome lung symptoms, response to treatment and relapse after withdrawal of treatment

    Measured: 3 years

Secondary outcomes (8)

  1. Asthma exacerbations

    Age at onset of severe asthma exacerbation diagnosed by predefined criteria of acute severe asthma requiring oral/high dose inhaled steroids or acute hospital contact

    Measured: 0-3 years

  2. Infections

    Main analysis:

    • Number of lower respiratory tract infections registered in daily diaries

    Secondary analyses:

    • Acute otitis media
    • Number of upper respiratory tract infections
    • Number of other infections
    • Total number of infections

    Measured: 0-3 years of age

  3. Growth

    • Body composition (fat mass and bone mineral density) assessed by DEXA scan at 3 years of age
    • Development of BMI from birth to 3 years assesses longitudinally in the research clinic

    Measured: 0 to 3 years of age

  4. Neurological development

    Main analysis:

    • Cognitive development assessed at 2½ years using the cognitive part of Bayley Scales of Infant and Toddler Development, third edition

    Secondary analyses:

    • Milestone development monitored prospectively by the parents using a registration form based on The Denver Development Index and WHO milestones registration (combined assessment by principal component analysis)
    • Language development assessed at 1 and 2 years of age with the Danish version of The MacArthur Bates Communicative Developmental Inventory (CDI)
    • The child´s general development (language, fine and gross motor, social and problem solving) at 3 years of age assessed with Ages and stages Questioner, third edition (ASQ-3)

    Measured: 0-3 years

  5. Eczema

    Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria

    Measured: 0-3 years

  6. Allergic sensitization

    Allergic sensitization at 6 and/or 18 months of age assessed by skin prick test and specific IgE in blood

    Measured: 6 and 18 months of age

  7. Systemic immune status

    Main analysis

    • Immune status at 18 months measured in stimulated whole blood as cytokine release (combined assessments by prinicipal component analyses) Secondary analyses
    • Composition of immune cell subsets in whole blood at birth and at 18 months of age

    Measured: 18 months

  8. Airway mucosal immune status

    Immune status measured in airway mucosal lining fluid at 4 weeks and 2 years of age (combined assessments by prinicipal component analyses for each age point)

    Measured: 4 weeks and 2 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2008 (estimated)
  2. Study start26 Nov 2008
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00798226
Sponsor's protocol ID
H-B-2008-093
Status last verified
Jun 2026
First submitted
25 Nov 2008
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No

Publications

  • Hernandez-Lorca M, Vestergaard MB, Ambrosen KS, Raghava JM, Lindberg U, Jepsen JRM, Rosenberg JB, Lemvigh CK, Mohammadzadeh P, Glenthoj BY, Chawes B, Vinding RK, Bonnelykke K, Larsson H, Ebdrup BH. Fish oil-derived fatty acids in pregnancy and brain metabolism in middle childhood: results from a randomized controlled trial. Transl Psychiatry. 2026 Jul 16. doi: 10.1038/s41398-026-04173-5. Online ahead of print.

    PubMed 42463642

  • Rantala AK, Hakola L, Brustad N, Tapia G, Hard Af Segerstad EM, Lehtonen J, Thorsen J, Akerlund M, Parr CL, Magnus MC, Lund-Blix NA, Stokholm J, Knip M, Toppari J, Stordal K, Veijola R, Hyoty H, Virtanen SM, Bonnelykke K, Stene LC; HEDIMED Investigator Group. Marine n-3 Long-Chain Polyunsaturated Fatty Acid Intake in Pregnancy and Risk of Early Life Infections in 3 Nordic Cohorts: A HEDIMED Consortium Study. J Nutr. 2026 May;156(5):101456. doi: 10.1016/j.tjnut.2026.101456. Epub 2026 Feb 28.

    PubMed 41771441

  • Chen L, Brustad N, Luo Y, Wang T, Ali M, Ebrahimi P, Schoos AM, Vahman N, Lovric M, Rasmussen MA, Kolmert J, Wheelock CE, Lasky-Su JA, Stokholm J, Bonnelykke K, Chawes B. Prenatal Fish Oil Supplementation, Maternal COX1 Genotype, and Childhood Atopic Dermatitis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2024 Oct 1;160(10):1082-1090. doi: 10.1001/jamadermatol.2024.2849.

    PubMed 39196551

  • Vinding RK, Sevelsted A, Horner D, Vahman N, Lauritzen L, Hagen CP, Chawes B, Stokholm J, Bonnelykke K. Fish oil supplementation during pregnancy, anthropometrics, and metabolic health at age ten: A randomized clinical trial. Am J Clin Nutr. 2024 Apr;119(4):960-968. doi: 10.1016/j.ajcnut.2023.12.015. Epub 2024 Feb 22.

    PubMed 38569788

  • Bisgaard H, Mikkelsen M, Rasmussen MA, Sevelsted A, Schoos AM, Brustad N, Eliasen AU, Thorsen J, Chawes B, Gurdeniz G, Morin A, Stark K, Stokholm J, Ober C, Pedersen CET, Bonnelykke K. Atopic and non-atopic effects of fish oil supplementation during pregnancy. Thorax. 2023 Dec;78(12):1168-1174. doi: 10.1136/thorax-2022-219725. Epub 2023 Sep 11.

    PubMed 37696621

  • Prince N, Kelly RS, Chu SH, Kachroo P, Chen Y, Mendez KM, Begum S, Bisgaard H, Bonnelykke K, Kim M, Levy O, Litonjua AA, Wheelock CE, Weiss ST, Chawes BL, Lasky-Su JA. Elevated third trimester corticosteroid levels are associated with fewer offspring infections. Sci Rep. 2023 Jun 28;13(1):10461. doi: 10.1038/s41598-023-36535-0.

    PubMed 37380711

  • Brustad N, Yang L, Chawes BL, Stokholm J, Gurdeniz G, Bonnelykke K, Bisgaard H. Fish Oil and Vitamin D Supplementations in Pregnancy Protect Against Childhood Croup. J Allergy Clin Immunol Pract. 2023 Jan;11(1):315-321. doi: 10.1016/j.jaip.2022.09.027. Epub 2022 Sep 30.

    PubMed 36184023

  • Horner D, Hjelmso MH, Thorsen J, Rasmussen M, Eliasen A, Vinding RK, Schoos AM, Brustad N, Sunde RB, Bonnelykke K, Chawes BL, Stokholm J, Bisgaard H. Supplementation With Fish Oil in Pregnancy Reduces Gastroenteritis in Early Childhood. J Infect Dis. 2023 Feb 1;227(3):448-456. doi: 10.1093/infdis/jiab607.

    PubMed 34927195

  • Vinding RK, Stokholm J, Sevelsted A, Chawes BL, Bonnelykke K, Barman M, Jacobsson B, Bisgaard H. Fish Oil Supplementation in Pregnancy Increases Gestational Age, Size for Gestational Age, and Birth Weight in Infants: A Randomized Controlled Trial. J Nutr. 2019 Apr 1;149(4):628-634. doi: 10.1093/jn/nxy204.

    PubMed 30418579

  • Vinding RK, Stokholm J, Sevelsted A, Sejersen T, Chawes BL, Bonnelykke K, Thorsen J, Howe LD, Krakauer M, Bisgaard H. Effect of fish oil supplementation in pregnancy on bone, lean, and fat mass at six years: randomised clinical trial. BMJ. 2018 Sep 4;362:k3312. doi: 10.1136/bmj.k3312.

    PubMed 30181143

  • Bisgaard H, Stokholm J, Chawes BL, Vissing NH, Bjarnadottir E, Schoos AM, Wolsk HM, Pedersen TM, Vinding RK, Thorsteinsdottir S, Folsgaard NV, Fink NR, Thorsen J, Pedersen AG, Waage J, Rasmussen MA, Stark KD, Olsen SF, Bonnelykke K. Fish Oil-Derived Fatty Acids in Pregnancy and Wheeze and Asthma in Offspring. N Engl J Med. 2016 Dec 29;375(26):2530-9. doi: 10.1056/NEJMoa1503734.

    PubMed 28029926

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing n-3 fatty acid and olive oil in people with Asthma and Eczema, run by Copenhagen Studies on Asthma in Childhood at 2 sites in Denmark.

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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Persistent wheeze 0 to 3 years of age (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00798226, which also lists 11 linked publications.

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 5 Jun 2026.

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