Vitamin D supplementation during pregnancy to prevent early childhood asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effects of high-dose vitamin D supplementation (3200 IU/day) compared to a placebo in pregnant women starting from gestational week 24 until one week after delivery. The trial will involve 2000 participants who will be randomized based on their maternal blood levels of EPA+DHA. The primary focus is to assess the impact of this supplementation on the development of asthma and persistent wheeze in children up to three years of age, alongside monitoring various secondary health outcomes. Maternal blood will also be analyzed for genetic, metabolomic, and proteomic profiling to understand potential effect modifications.

Why it matters

Who can join: the full rules

* 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

Where it's running

• Copenhagen University Hospital of Copenhagen
  Gentofte Municipality, Denmark Recruiting

Study contacts

• Principal investigator: Klaus Bønnelykke, PhD — Copenhagen Studies on Asthma in Childhood
• Study coordinator: Klaus Bønnelykke, PhD
• Email: kb@copsac.com
• Phone: +4538677360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.