Professor Klaus Bonnelykke
Professor Klaus Bonnelykke
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.
Asthma
Respiratory Tract Infections
Gastrointestinal Infection
Croup
Eczema
Allergy
Wheezing
Fractures, Bone
Development, Child
Cognition Disorders in Children
Psychiatric Diagnosis
Cholecalciferol D3
Olive oil
PHASE3
Randomization of 2000 pregnant women to vitamin D of high-dose (3200 IU/day) vitamin D vs placebo on top of the recommended 400 IU/day. Supplementation begins in gestational week 24 (22-26) until 1 week after delivery. Allocation to the trial will be determined based on the pre-interventional maternal blood levels of EPA+DHA with a dried blood screening test. Women with high levels (above 4.7% of total fatty acids) will be assigned to the vitamin D RCT. Maternal blood will be used for genetic, metabolomic and proteomic profiling. A 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. The primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. Secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. A follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 2000 participants |
| Masking : | QUADRUPLE |
| Primary Purpose : | PREVENTION |
| Official Title : | VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY) |
| Actual Study Start Date : | 2024-12-20 |
| Estimated Primary Completion Date : | 2026-10 |
| Estimated Study Completion Date : | 2033-03 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 45 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Copenhagen University Hospital of Copenhagen
Gentofte Municipality, Denmark, DK-2820