Vitamin D supplementation during pregnancy to prevent early childhood asthma
VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)
This study is testing if giving high-dose vitamin D to pregnant women can help prevent asthma and wheezing in their children by the time they reach three years old.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Copenhagen Studies on Asthma in Childhood Academic / other |
| Locations | 1 site (Gentofte Municipality) |
| Trial ID | NCT06570889 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant Danish women before week 26 with specific blood levels of EPA+DHA and no current high vitamin D intake.
Not a fit: Patients with endocrine, heart, kidney, or autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of asthma and related respiratory issues in early childhood.
How similar studies have performed: Previous studies have suggested potential benefits of vitamin D supplementation in pregnancy, but this specific high-dose approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Gentofte Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.