High-dose vitamin D to prevent asthma-like symptoms in young children
Tests high-dose vitamin D3 in children aged 1 to 5 with asthma.
Plain-language title generated from the registry record
Registry title: High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children
Key facts
- Where
- Gentofte Municipality, DenmarkSee the site
- Phase
- Phase 2
Where in Denmark
- University Hospital of CopenhagenGentofte Municipality, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Copenhagen Studies on Asthma in Childhood
- Trial code
- NCT05043116
- Record updated
- 16 April 2025
- Original description
To investigate whether high-dose vitamin D supplementation may have a beneficial effect on secondary prevention in preschool children (1-5 years of age), with respiratory infections being the primary cause of acute exacerbations with asthma-like symptoms.Read full original descriptionShow less
High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children - a Double-blind, Randomized, Controlled Trial
To investigate whether high-dose vitamin D supplementation may have a beneficial effect on secondary prevention in preschool children (1-5 years of age), with respiratory infections being the primary cause of acute exacerbations with asthma-like symptoms.
Inclusion: The study population consists of children in the age group 1-5 years admitted to a pediatric ward, due to an acute episode with asthma-like symptoms. An acute asthma-like episode will be defined as annoying coughing, wheezing (wheezing or wheezing in connection with exhalation) and / or dyspnoea, which affects the child's well-being and requires hospitalization in a pediatric ward. Participation in the study requires that the child is in or has been in treatment with SABA, as monotherapy, or in combination with ICS, and possibly also in combination with LTRA in accordance with the Danish guidelines.
Exclusion: The child has other chronic lung diseases; The child is diagnosed with other conditions such as chronic lung disease, impaired renal function, neurological or psychiatric disorders, congenital or documented acquired QT prolongation, clinically relevant bradycardia, cardiac arrhythmia or severe heart failure and / or hepatic impairment; The child is being treated with medication that alters calcium or vitamin D absorption / metabolism; The child is given a combination of vitamin and dietary supplements containing vitamin D, thus the daily recommended dose is exceeded, as 2400 IU / day (~ 60 μg / day) is accepted for children aged 1-4 years, as everyone here is recommended to take 400 IU / day (~ 10 μg / day) by the Danish Health and Medicines Authority; The child is malnourished; for children> 2 years of age whose age-specific BMI is less than the 3rd percentile; for children <2 years, whose weight or height in relation to age is less than the 3rd percentile; The child is hospitalized with pneumonia; The child's daily intake of vitamin D supplementation is> 400 IU / day (~ 10 μg / day); The baby has been exclusively breastfed for the past 6 months; The child is a newly arrived refugee or immigrant from regions with a high risk of rickets.