High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children

Launched by COPENHAGEN STUDIES ON ASTHMA IN CHILDHOOD · Sep 3, 2021

Keywords

ClinConnect Summary

This clinical trial is looking into whether giving high doses of vitamin D can help prevent asthma-like symptoms in preschool children aged 1 to 5 years who have had respiratory infections. These infections often lead to episodes of coughing, wheezing, and difficulty breathing, which can be serious enough to require hospital treatment. The goal is to see if vitamin D can reduce the chances of these episodes happening again.

To participate in the study, children must have been hospitalized due to asthma-like symptoms and have received certain asthma treatments. However, children who are being treated for pneumonia, are already taking too much vitamin D, or have other serious health issues will not be eligible. If a child joins the study, they will receive vitamin D supplements and will be monitored for any changes in their asthma-like symptoms. This trial is currently recruiting participants, and it aims to provide valuable insights into managing asthma in young children.

Gender

ALL

Eligibility criteria

• 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.