About this trial
The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant Danish women before week 26 with blood levels of EPA+DHA above 4.7% of total fatty acids
No current vitamin D intake above the recommended 400 IU/day
No endocrine-, heart-, kidney- or auto-immune disorders
No disorders requiring treatment with blood thinning medication
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Cholecalciferol D3
Dietary supplementOral intake of 1 capsule per day from week 22-26 in pregnancy to 1 week after delivery
Olive oil
Other interventionOral intake of 1 capsule per day from week 22-26 in pregnancy to 1 week after delivery
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Atopic/non-atopic wheeze or asthma age 0-3 years
Parental reports of physician diagnosed asthma in combination with eczema and/or allergic rhinitis. Outcome analyses: asthma/persistent wheeze with/without eczema and/or allergic rhinitis (yes/no) by age 3 years. Each subtype is compared with children without asthma.
Troublesome lung symptoms age 0-3 years
Defined as cough, wheeze or dyspnea severely affecting the well-being of the child for at least 3 consecutive days based on parental reports. Outcome analyses: total no. of episodes with symptoms age 0-3 years.
Wheeze episodes age 0-3 years
Parental reports of wheezing. Outcome analyses: total no. of episodes with wheeze age 0-3 years.
Inhaled bronchodilator use from parental reports age 0-3 years
Outcome analyses: total no. of days with bronchodilator use age 0-3.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Professor Klaus Bønnelykke
Lead sponsor
Copenhagen Studies on Asthma in Childhood
Sponsor institution