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

NCT00798226 | Active Not Recruiting Phase 1

• 1 other identifier: H-B-2008-093
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Asthma; Eczema; Sensitization; Allergy

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (8)

• Asthma exacerbations

  0-3 years

• Infections

  0-3 years of age

• Growth

  0 to 3 years of age

• Neurological development

  0-3 years

• Eczema

  0-3 years

Other Outcomes (27)

• Asthma

  3-10 years of age

• Infections

  3-10 years of age

• Weight

  3-10 years of age

Study Arms (2)

1

ACTIVE COMPARATOR

n-3 fatty acid

Dietary Supplement: n-3 fatty acid

2

PLACEBO COMPARATOR

Olive oil

Dietary Supplement: olive oil

Interventions

n-3 fatty acid DIETARY_SUPPLEMENT

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

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

1

olive oil DIETARY_SUPPLEMENT

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

Also known as: Pharmatech AS, Po 85, 1662 Rolvsøy, Norway

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participating in other clinical trial

Sponsors & Collaborators

• Copenhagen Studies on Asthma in Childhood: lead

Study Sites (2)

Copenhagen University Hospital of Copenhagen

Gentofte Municipality, Gentofte, 2820, Denmark

Location

Næstved Hospital, Pediatric Department

Næstved, Næstved, 4700, Denmark

Location

Related Publications (9)

• 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.

  PMID: 39196551 DERIVED

• 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.

  PMID: 38569788 DERIVED

• 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.

  PMID: 37696621 DERIVED

• 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.

  PMID: 37380711 DERIVED

• 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.

  PMID: 36184023 DERIVED

• 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.

  PMID: 34927195 DERIVED

• 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.

  PMID: 30418579 DERIVED

• 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.

  PMID: 30181143 DERIVED

• 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.

  PMID: 28029926 DERIVED

MeSH Terms

Conditions

Asthma; Eczema; Hypersensitivity

Interventions

Fatty Acids, Omega-3; Olive Oil

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Klaus Bønnelykke, MD, PhD

  COPSAC / University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: November 26, 2008
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)