Clinical trial NCT00798226: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Asthma
Eczema
Allergy
Keywords: Asthma
Eczema
Sensitization
Allergy
Lead sponsor: Copenhagen Studies on Asthma in Childhood
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Persistent wheeze 0 to 3 years of age
timeFrame: 3 years
Secondary outcomes:
measure: Asthma exacerbations
timeFrame: 0-3 years
measure: Infections
timeFrame: 0-3 years of age
measure: Growth
timeFrame: 0 to 3 years of age
measure: Neurological development
timeFrame: 0-3 years
measure: Eczema
timeFrame: 0-3 years
measure: Allergic sensitization
timeFrame: 6 and 18 months of age
measure: Systemic immune status
timeFrame: 18 months
measure: Airway mucosal immune status
timeFrame: 4 weeks and 2 years of age
Other outcomes:
measure: Asthma
timeFrame: 3-10 years of age
measure: Infections
timeFrame: 3-10 years of age
measure: Weight
timeFrame: 3-10 years of age
measure: Behavioral and psychopathological dimensions.
timeFrame: 10 years of age
measure: MRI scanning of the brain
timeFrame: 10 years of age
measure: Eczema
timeFrame: 3-10 years of age
measure: Allergic sensitization/atopy
timeFrame: 6-10 years of age
measure: Airway mucosal immune status:
timeFrame: 3-10 years of age
measure: Allergic rhinitis
timeFrame: 3-10 years of age
measure: Lung function measurements
timeFrame: [Time Frame: 5-10 years of age]
measure: Cognitive function
timeFrame: 10 years of age
measure: Asthma exacerbations:
timeFrame: [Time Frame: 3-10 years of age]
measure: Body composition:
timeFrame: [Time Frame: 3-13 years of age]
measure: Airway resistance
timeFrame: [Time Frame: 3-10 years of age]
measure: Airway resistance
timeFrame: [Time Frame: 3-5 years of age]
measure: Bronchial reactivity:
timeFrame: 6 years of age.
measure: Airway inflammation:
timeFrame: [Time Frame: 6-10 years of age]
measure: Height
timeFrame: [Time Frame: 3-10 years of age]
measure: Waistcircumference
timeFrame: [Time Frame: 3-10 years of age]
measure: Headcircumference
timeFrame: [Time Frame: 3-10 years of age]
measure: Thoraxcircumference
timeFrame: [Time Frame: 3-10 years of age]
measure: Strength and Difficulties Questionnaire (SDQ)- Questionnaires
timeFrame: 6, 8 and 10 years of age.
measure: ADHD- RS- Questionnaires
timeFrame: 8 and 10 years of age.
measure: Social Responsive Scale, Second version (SRS-2)
timeFrame: 10 years of age
measure: The Behavior Rating Inventory of Executive Function 2nd edition (BRIEF-2)
timeFrame: 10 years of age
measure: The Child Behavior Checklist school-age version (CBCL)
timeFrame: 10 years of age
measure: Allergic sensitization
timeFrame: 6 and 10 years of age
Locations:
city: Gentofte
country: Denmark
facility: Copenhagen University Hospital of Copenhagen
city: Næstved
country: Denmark
facility: Næstved Hospital, Pediatric Department
Study officials:
affiliation: COPSAC / University of Copenhagen
name: Klaus Bønnelykke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.