NCT05043116RecruitingPhase 2
High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children
High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children - a Double-blind, Randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 21 May 2021
- Start date
- Oct 2022
- Primary completion date
- Oct 2028
- Lead sponsor
- Copenhagen Studies on Asthma in Childhood
- Diseases
- Asthma
- NCT number
- NCT05043116
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 320
- From Oct 2022 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The child has other chronic lung diseases.
Lab values
- 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.
Age
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 12 months to 71 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Copenhagen Coordinator of this site? Confirm its status | Gentofte Municipality | Denmark | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.