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

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ClinicalTrials.gov Identifier: NCT00798226
Recruitment Status : Active, not recruiting
First Posted : November 26, 2008
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Copenhagen Studies on Asthma in Childhood

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.

Condition or disease Intervention/treatment Phase
Asthma Eczema Allergy Dietary Supplement: n-3 fatty acid Dietary Supplement: olive oil Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 26, 2008
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma Eczema
Drug Information available for: Olive oil

Arm Intervention/treatment
Active Comparator: 1
n-3 fatty acid
Dietary Supplement: n-3 fatty acid
Oral intake of 4 capsules daily from week 24 of gestation to 1 week after delivery
Other Name: Incromega (Croda Nordica AB), Krossverksgatan 5 C, SE-216 16 Limhamn, Sweden

Placebo Comparator: 2
Olive oil
Dietary Supplement: olive oil
Oral intake of 4 capsules (1 g) daily from 24 weeks of gestation to 1 week after delivery
Other Name: Pharmatech AS, Po 85, 1662 Rolvsøy, Norway




Primary Outcome Measures :
  1. Persistent wheeze 0 to 3 years of age [ Time Frame: 3 years ]
    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 :
  1. Asthma exacerbations [ Time Frame: 0-3 years ]
    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

  2. Infections [ Time Frame: 0-3 years of age ]

    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

  3. Growth [ Time Frame: 0 to 3 years of age ]
    • 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

  4. Neurological development [ Time Frame: 0-3 years ]

    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)

  5. Eczema [ Time Frame: 0-3 years ]
    Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria

  6. Allergic sensitization [ Time Frame: 6 and 18 months of age ]
    Allergic sensitization at 6 and/or 18 months of age assessed by skin prick test and specific IgE in blood

  7. Systemic immune status [ Time Frame: 18 months ]

    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

  8. Airway mucosal immune status [ Time Frame: 4 weeks and 2 years of age ]
    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)


Other Outcome Measures:
  1. Asthma [ Time Frame: 3-10 years of age ]
    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.

  2. Infections [ Time Frame: 3-10 years of age ]
    Prescribed medicine for infections. Types and length of infections

  3. Weight [ Time Frame: 3-10 years of age ]
    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.

  4. Behavioral and psychopathological dimensions. [ Time Frame: 10 years of age ]

    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.


  5. MRI scanning of the brain [ Time Frame: 10 years of age ]
    MRI scanning of the brain. The scanning procedure will take up to 1 hour.

  6. Eczema [ Time Frame: 3-10 years of age ]
    Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria.

  7. Allergic sensitization/atopy [ Time Frame: 6-10 years of age ]
    Allergic sensitization at 6 and 10 years of age assessed by skin prick test (ALK-Abelló, Denmark).

  8. Airway mucosal immune status: [ Time Frame: 3-10 years of age ]
    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).

  9. Allergic rhinitis [ Time Frame: 3-10 years of age ]
    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.

  10. Lung function measurements [ Time Frame: [Time Frame: 5-10 years of age] ]
    Spirometry measuring airflow in liter. Compared with age and sex validated standards

  11. Cognitive function [ Time Frame: 10 years of age ]
    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 .

  12. Asthma exacerbations: [ Time Frame: [Time Frame: 3-10 years of age] ]
    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

  13. Body composition: [ Time Frame: [Time Frame: 3-10 years of age] ]

    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.


  14. Airway resistance [ Time Frame: [Time Frame: 3-10 years of age] ]
    sRaw measured by plethysmography at age 3, 4, 5, 6, 8 and 10 years.

  15. Airway resistance [ Time Frame: [Time Frame: 3-5 years of age] ]
    Multiple breath wash-out using SF6 and N2 as inert gasses to determined LCI, Scond and Sacin at ages 3, 4 and 5 years.

  16. Bronchial reactivity: [ Time Frame: 6 years of age. ]
    Provocative dose of methacholine leading to a 20% drop in FEV1 from baseline (PD20 value) at age 6 years.

  17. Airway inflammation: [ Time Frame: [Time Frame: 6-10 years of age] ]
    Measurement of fractional exhaled nitric oxide (FeNO) at age 6, 8 and 10 years

  18. Height [ Time Frame: [Time Frame: 3-10 years of age] ]
    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.

  19. Waistcircumference [ Time Frame: [Time Frame: 3-10 years of age] ]
    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.

  20. Headcircumference [ Time Frame: [Time Frame: 3-10 years of age] ]
    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.

  21. Thoraxcircumference [ Time Frame: [Time Frame: 3-10 years of age] ]
    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.

  22. Strength and Difficulties Questionnaire (SDQ)- Questionnaires [ Time Frame: 6, 8 and 10 years of age. ]
    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

  23. ADHD- RS- Questionnaires [ Time Frame: 8 and 10 years of age. ]

    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.


  24. Social Responsive Scale, Second version (SRS-2) [ Time Frame: 10 years of age ]
    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.

  25. The Behavior Rating Inventory of Executive Function 2nd edition (BRIEF-2) [ Time Frame: 10 years of age ]

    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.


  26. The Child Behavior Checklist school-age version (CBCL) [ Time Frame: 10 years of age ]

    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.


  27. Allergic sensitization [ Time Frame: 6 and 10 years of age ]
    Allergic sensitization assessed specific IgE in blood (ImmunoCAP, PHarmacia Diagnostics AB, Sweden).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798226


Locations
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Denmark
Copenhagen University Hospital of Copenhagen
Gentofte, Denmark, 2820
Næstved Hospital, Pediatric Department
Næstved, Denmark, 4700
Sponsors and Collaborators
Copenhagen Studies on Asthma in Childhood
Investigators
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Principal Investigator: Hans Bisgaard, MD, DMSc COPSAC / University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier: NCT00798226    
Other Study ID Numbers: H-B-2008-093
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Keywords provided by Copenhagen Studies on Asthma in Childhood:
Asthma
Eczema
Sensitization
Allergy
Additional relevant MeSH terms:
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Asthma
Eczema
Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Dermatitis
Skin Diseases
Skin Diseases, Eczematous