Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials.
Nicklas Brustad, Nilo Vahman, Ulrik Ralfkiaer...
https://pubmed.ncbi.nlm.nih.gov/39740942Actively Recruiting
Led by Professor Klaus Bønnelykke · Updated on 2025-09-30
2000
Participants Needed
1
Research Sites
334 weeks
Total Duration
Researchers are studying whether taking higher doses of vitamin D during pregnancy can help prevent early childhood asthma or persistent wheezing in children up to 3 years old. The study targets pregnant women with higher levels of certain fatty acids in their blood. It also looks at other child health outcomes such as respiratory infections, eczema, allergies, bone fractures, development, mental health, and growth, following children until age 6 for some outcomes. Pregnant women are randomly assigned to take either a high dose of vitamin D (3200 IU daily) or a placebo capsule containing olive oil, starting between week 22 and 26 of pregnancy and continuing until one week after delivery. All participants also receive the recommended standard dose of 400 IU vitamin D. Blood samples will be collected for genetic and metabolic studies. The children will be followed for 3 years, with plans for extended follow-up until age 6 after the study is unblinded. Participants will be monitored through parent-reported symptoms, medical records, and registrations of medication use and hospital visits for their children. Researchers will assess lung and allergy symptoms, infections, developmental milestones, and mental health among other measures. The study includes regular data collection during the 3-year follow-up period and ongoing evaluation of health outcomes to better understand the impact of prenatal vitamin D supplementation on early childhood health.
CONDITIONS
VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit for blood screening test
Duration - Approximately 16 weeks (from gestational week 22-26 until 1 week post-delivery)
Participants take vitamin D or placebo capsules daily from around week 22-26 of pregnancy until 1 week after delivery.
Daily capsule intake; visit schedule not specified
Duration - Up to 6 years
Participants' children are followed for health outcomes including asthma, infections, allergies, development, and growth until 6 years of age.
Longitudinal parent-reported symptom and health data collection; visit schedule not specified
Total: 1 location
1
Copenhagen University Hospital of Copenhagen
Gentofte Municipality, Denmark, DK-2820
Actively Recruiting
K
Klaus Bønnelykke, PhD
U
Ulrik Ralfkiaer, PhD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Nicklas Brustad, Nilo Vahman, Ulrik Ralfkiaer...
https://pubmed.ncbi.nlm.nih.gov/39740942