High-dose Vitamin D to prevent asthma-like symptoms in young children

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 investigates the effects of high-dose vitamin D supplementation on preventing acute asthma-like symptoms in preschool children aged 1-5 years. It focuses on children admitted to a pediatric ward due to episodes characterized by coughing, wheezing, and difficulty breathing, often triggered by respiratory infections. The intervention involves administering cholecalciferol D3 compared to a placebo to assess its efficacy in reducing the frequency of these acute episodes. The study aims to address the growing prevalence of asthma and its significant impact on young children's health and well-being.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

* The child is hospitalized with pneumonia
* The child's daily intake of vitamin D supplementation is\> 400 IU / day (\~ 10 μg / day).
* 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 baby has been exclusively breastfed for the past 6 months.
* 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 a newly arrived refugee or immigrant from regions with a high risk of rickets.
* 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.

Where it's running

• University Hospital of Copenhagen
  Gentofte Municipality, Gentofte, Denmark Recruiting

Study contacts

• Principal investigator: Bo Chawes, MD, DMSc — chawes@copsac.com
• Study coordinator: Klaus Bønnelykke, MD, 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.