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

NCT ID: NCT00798226

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-26

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Eczema Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

n-3 fatty acid

Group Type ACTIVE_COMPARATOR

n-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

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

2

Olive oil

Group Type PLACEBO_COMPARATOR

olive oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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n-3 fatty acid

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

Intervention Type DIETARY_SUPPLEMENT

olive oil

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Incromega (Croda Nordica AB), Krossverksgatan 5 C, SE-216 16 Limhamn, Sweden Pharmatech AS, Po 85, 1662 Rolvsøy, Norway

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Participating in other clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Copenhagen Studies on Asthma in Childhood

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Bønnelykke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

COPSAC / University of Copenhagen

Locations

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Copenhagen University Hospital of Copenhagen

Gentofte Municipality, Gentofte, Denmark

Site Status

Næstved Hospital, Pediatric Department

Næstved, Næstved, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 39196551 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38569788 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37696621 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37380711 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36184023 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34927195 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30418579 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30181143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28029926 (View on PubMed)

Other Identifiers

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H-B-2008-093

Identifier Type: -

Identifier Source: org_study_id

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