Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

NCT06560255 | Recruiting Phase 3

• 1 other identifier: H-23055833-F
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development.

Conditions

Asthma; Respiratory Tract Infections; Gastrointestinal Infection; Croup; Eczema; Allergy; Wheezing; Fractures, Bone; Development, Child; Cognition Disorders in Children; Psychiatric Diagnosis

Keywords

Childhood; Asthma; Infections; Eczema; Allergy; Development; Psychiatry; Bone development; Cognition; Growth

Outcome Measures

Primary Outcomes (1)

• Early childhood asthma/persistent wheeze age 0-3 years

  Defined as either a) parental report of a minimum of 2 wheeze episodes with at least 1 after the child's second birthday and redemption of at least 2 prescriptions of asthma controller medication with at least 1 being after the child's second birthday or b) a minimum of 2 ED visits or hospitalizations due to asthmatic symptoms, and at least 1 of these being after the child's second birthday or c) parental report of physician-diagnosed asthma age 0-3 years Outcome analysis: risk (survival analysis) of persistent wheeze or asthma at age 0-3 years.

  3 years

Secondary Outcomes (44)

• Atopic/non-atopic wheeze or asthma age 0-3 years

  3 years

• Troublesome lung symptoms age 0-3 years

  3 years

• Wheeze episodes age 0-3 years

  3 years

• Inhaled bronchodilator use from parental reports age 0-3 years

  3 years

• Inhaled bronchodilator prescriptions from medical record checks age 0-3 years

  3 years

Study Arms (2)

n-3 fatty acid of 2.4 g per day

EXPERIMENTAL

Oral intake of 4 capsules daily from week 22-26 of gestation until 1 week after delivery

Dietary Supplement: n-3 fatty acid

Rape seed oil

PLACEBO COMPARATOR

Oral intake of 4 capsules daily from week 22-26 of gestation until 1 week after delivery

Other: Rape seed oil

Interventions

n-3 fatty acid DIETARY_SUPPLEMENT

Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Also known as: GoldenOmega, PharmaNord, DK

n-3 fatty acid of 2.4 g per day

Rape seed oil OTHER

Oral intake of 4 capsules per day from week 22-26 in pregnancy to 1 week after delivery

Also known as: Placebo capsules, PharmaNord, DK

Rape seed oil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

* Pregnant Danish women before week 26 with blood levels of EPA+DHA below 4.7% of total fatty acids * No planned use of fish oil supplementations * No endocrine-, heart-, kidney- or auto-immune disorders * No disorders requiring treatment with blood thinning medication

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Professor Klaus Bønnelykke: lead

Study Sites (1)

Copenhagen University Hospital of Copenhagen

Gentofte Municipality, DK-2820, Denmark

RECRUITING

Related Publications (1)

• Brustad N, Vahman N, Ralfkiaer U, Mikkelsen M, Brandt S, Kyvsgaard JN, Vinding R, Stokholm J, Chawes B, Bonnelykke K. Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials. BMJ Open. 2024 Dec 31;14(12):e092902. doi: 10.1136/bmjopen-2024-092902.

  PMID: 39740942 DERIVED

MeSH Terms

Conditions

Asthma; Respiratory Tract Infections; Croup; Eczema; Hypersensitivity; Respiratory Sounds; Fractures, Bone; Mental Disorders; Infections

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Laryngitis; Laryngeal Diseases; Otorhinolaryngologic Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Bo Chawes, PhD

  Copenhagen Studies on Asthma in Childhood

  PRINCIPAL INVESTIGATOR

• Klaus Bønnelykke, PhD

  Copenhagen Studies on Asthma in Childhood

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Bønnelykke, PhD

CONTACT

+45 38677360; kb@copsac.com

Ulrik Ralfkiaer, PhD

CONTACT

+45 38674164; administration@dbac.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor PhD, Head of COPSAC

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2033
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)