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

Primary Purpose

Asthma, Eczema, Allergy

Status
Active
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
n-3 fatty acid
olive oil
Sponsored by
Copenhagen Studies on Asthma in Childhood
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma, Eczema, Sensitization, Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria (mother):

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

Exclusion Criteria (mother):

  • Participating in other clinical trial

Sites / Locations

  • Copenhagen University Hospital of Copenhagen
  • Næstved Hospital, Pediatric Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

n-3 fatty acid

Olive oil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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)
Eczema
Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria
Allergic sensitization
Allergic sensitization at 6 and/or 18 months of age assessed by skin prick test and specific IgE in blood
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
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)

Full Information

First Posted
November 25, 2008
Last Updated
November 14, 2022
Sponsor
Copenhagen Studies on Asthma in Childhood
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1. Study Identification

Unique Protocol Identification Number
NCT00798226
Brief Title
Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2008 (Actual)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen Studies on Asthma in Childhood

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Eczema, Allergy
Keywords
Asthma, Eczema, Sensitization, Allergy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
n-3 fatty acid
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Olive oil
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 fatty acid
Other Intervention Name(s)
Incromega (Croda Nordica AB), Krossverksgatan 5 C, SE-216 16 Limhamn, Sweden
Intervention Description
Oral intake of 4 capsules daily from week 24 of gestation to 1 week after delivery
Intervention Type
Dietary Supplement
Intervention Name(s)
olive oil
Other Intervention Name(s)
Pharmatech AS, Po 85, 1662 Rolvsøy, Norway
Intervention Description
Oral intake of 4 capsules (1 g) daily from 24 weeks of gestation to 1 week after delivery
Primary Outcome Measure Information:
Title
Persistent wheeze 0 to 3 years of age
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Asthma exacerbations
Description
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
Time Frame
0-3 years
Title
Infections
Description
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
Time Frame
0-3 years of age
Title
Growth
Description
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
Time Frame
0 to 3 years of age
Title
Neurological development
Description
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)
Time Frame
0-3 years
Title
Eczema
Description
Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria
Time Frame
0-3 years
Title
Allergic sensitization
Description
Allergic sensitization at 6 and/or 18 months of age assessed by skin prick test and specific IgE in blood
Time Frame
6 and 18 months of age
Title
Systemic immune status
Description
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
Time Frame
18 months
Title
Airway mucosal immune status
Description
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)
Time Frame
4 weeks and 2 years of age
Other Pre-specified Outcome Measures:
Title
Asthma
Description
Asthma diagnosed from age 3 to 10 years based on the same predefined algorithm of recurrent troublesome lung symptoms, response to treatment after withdrawal of treatment, which was used for persistent wheeze at age 0-3 in phase 1 of the study. Primary outcome in phase 2 is current asthma at specific visits till age 10 years, which is diagnosed in children fulfilling the persistent wheeze algorithm at any point during the first 10 years of life and still needing inhaled corticosteroids at specific visits (3, 4, 5, 6, 8 and 10 years of age) to control the symptoms.
Time Frame
3-10 years of age
Title
Infections
Description
Prescribed medicine for infections. Types and length of infections
Time Frame
3-10 years of age
Title
Weight
Description
Clinical follow up on the development of weight in kg (calibrated digital weight scales) at every visit till age 10 years assessed longitudinally in the research clinic.
Time Frame
3-10 years of age
Title
Behavioral and psychopathological dimensions.
Description
Behavioral and psychopathological dimensions will be assessed at 10 years of age. The childrens' potential psychiatric diagnoses will be ascertained through the semi-structured clinical interview Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (K-SADS-PL) first with a parent and next with the child.
Time Frame
10 years of age
Title
MRI scanning of the brain
Description
MRI scanning of the brain. The scanning procedure will take up to 1 hour.
Time Frame
10 years of age
Title
Eczema
Description
Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria.
Time Frame
3-10 years of age
Title
Allergic sensitization/atopy
Description
Allergic sensitization at 6 and 10 years of age assessed by skin prick test (ALK-Abelló, Denmark).
Time Frame
6-10 years of age
Title
Airway mucosal immune status:
Description
Immune status measured in airway mucosal lining fluid at 3, 6 and 10 years of age (combined assessments by principal component analyses for each age point).
Time Frame
3-10 years of age
Title
Allergic rhinitis
Description
Allergic rhinitis will be diagnosed by combining allergic sensitization with symptom recording of troublesome congestion or sneezing or runny nose upon relevant exposure to allergens at age 3, 4, 5, 6, 8 and 10 years.
Time Frame
3-10 years of age
Title
Lung function measurements
Description
Spirometry measuring airflow in liter. Compared with age and sex validated standards
Time Frame
[Time Frame: 5-10 years of age]
Title
Cognitive function
Description
A 2,5 hours cognitive evaluation at 10 years of age. Cognitive functions from a broad spectrum of cognitive domains will be assessed with subtests both using paper pencil tests and Cambridge Neuropsychological Test Automated Battery .
Time Frame
10 years of age
Title
Asthma exacerbations:
Description
Age at onset and number of severe asthma exacerbation diagnosed by predefined criteria of acute severe asthma requiring oral/ high dose inhaled steroids or acute hospital contact
Time Frame
[Time Frame: 3-10 years of age]
Title
Body composition:
Description
Body composition measured as fat mass, lean mass, bone mineral content (BMC) and bone mineral density assessed (BMD) through DXA scans at 6 years of age. Body impedance measurements at 10 years of age.
Time Frame
[Time Frame: 3-10 years of age]
Title
Airway resistance
Description
sRaw measured by plethysmography at age 3, 4, 5, 6, 8 and 10 years.
Time Frame
[Time Frame: 3-10 years of age]
Title
Airway resistance
Description
Multiple breath wash-out using SF6 and N2 as inert gasses to determined LCI, Scond and Sacin at ages 3, 4 and 5 years.
Time Frame
[Time Frame: 3-5 years of age]
Title
Bronchial reactivity:
Description
Provocative dose of methacholine leading to a 20% drop in FEV1 from baseline (PD20 value) at age 6 years.
Time Frame
6 years of age.
Title
Airway inflammation:
Description
Measurement of fractional exhaled nitric oxide (FeNO) at age 6, 8 and 10 years
Time Frame
[Time Frame: 6-10 years of age]
Title
Height
Description
Clinical follow up on the development of height in cm (Harpenden stadiometer) at every visit till age 10 years assessed longitudinally in the research clinic.
Time Frame
[Time Frame: 3-10 years of age]
Title
Waistcircumference
Description
Clinical follow up on the development of waistcircumference in cm(using tape; 3 times each) at every visit till age 10 years assessed longitudinally in the research clinic.
Time Frame
[Time Frame: 3-10 years of age]
Title
Headcircumference
Description
Clinical follow up on the development of headcircumference in cm(using tape; 3 times each) at every visit till age 10 years assessed longitudinally in the research clinic.
Time Frame
[Time Frame: 3-10 years of age]
Title
Thoraxcircumference
Description
Clinical follow up on the development of thoraxcircumference in cm(using tape; 3 times each) at every visit till age 10 years assessed longitudinally in the research clinic.
Time Frame
[Time Frame: 3-10 years of age]
Title
Strength and Difficulties Questionnaire (SDQ)- Questionnaires
Description
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds. Questionnaires will be administered to the parents to obtain their evaluation of their child's potential psychopathology and behavior problems. Scores will be calculated form the questionnaires in order validated methods
Time Frame
6, 8 and 10 years of age.
Title
ADHD- RS- Questionnaires
Description
The ADHD Rating Scale obtains parent ratings regarding the frequency of each ADHD symptom based on DSM criteria. Questionnaires will be administered to the parents to obtain their evaluation of their child's potential psychopathology and behavior problems. Scores will be calculated form the questionnaires. Scores will be calculated form the questionnaires in order validated methods.
Time Frame
8 and 10 years of age.
Title
Social Responsive Scale, Second version (SRS-2)
Description
The SRS-2 identifies social impairment associated with autism spectrum disorders (ASDs) and quantifies its severity Questionnaires will be administered to the parents to obtain their evaluation of their child's potential psychopathology. Scores will be calculated form the questionnaires. Scores will be calculated form the questionnaires in order validated methods.
Time Frame
10 years of age
Title
The Behavior Rating Inventory of Executive Function 2nd edition (BRIEF-2)
Description
The BRIEF-2 is a set of questionnaires for parents and teachers , designed to evaluate executive function from multiple perspectives. Questionnaires will be administered to the parents to obtain their evaluation of their child's potential psychopathology. Scores will be calculated form the questionnaires. Scores will be calculated form the questionnaires in order validated methods.
Time Frame
10 years of age
Title
The Child Behavior Checklist school-age version (CBCL)
Description
The Child Behavior Checklist (CBCL) is a widely used questionnaire to assess behavioral and emotional problems. Questionnaires will be administered to the parents to obtain their evaluation of their child's potential psychopathology and behavior problems. Scores will be calculated form the questionnaires. Scores will be calculated form the questionnaires in order validated methods.
Time Frame
10 years of age
Title
Allergic sensitization
Description
Allergic sensitization assessed specific IgE in blood (ImmunoCAP, PHarmacia Diagnostics AB, Sweden).
Time Frame
6 and 10 years of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (mother): Pregnant women Living in Sealand, Denmark Fluent in Danish Language Willing to let the newborn child participate in the study Exclusion Criteria (mother): Participating in other clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Bønnelykke, MD, PhD
Organizational Affiliation
COPSAC / University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital of Copenhagen
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Næstved Hospital, Pediatric Department
City
Næstved
ZIP/Postal Code
4700
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30418579
Citation
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.
Results Reference
derived
PubMed Identifier
30181143
Citation
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.
Results Reference
derived
PubMed Identifier
28029926
Citation
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.
Results Reference
derived

Learn more about this trial

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

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