High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children - a Double-blind, Randomized, Controlled Trial

Who is this study for? Preschool children with acute asthma-like symptoms
What treatments are being studied? Cholecalciferol
Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 5
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
University Hospital of Copenhagen
RECRUITING
Gentofte Municipality
Contact Information
Primary
Klaus Bønnelykke, MD, PhD
kb@copsac.com
+4538677360
Backup
Ulrik Ralfkiaer, MSc, PhD
administration@dbac.dk
+4538674164
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2031-10-01
Participants
Target number of participants: 320
Treatments
Active_comparator: Vitamin D
Dietary supplement: 2000 IU Vitamin D3 daily dose (oral suspension) for one year.
Placebo_comparator: Placebo
Oral suspension with no active substance, identical to the active suspension for one year.
Related Therapeutic Areas
Sponsors
Leads: Copenhagen Studies on Asthma in Childhood

This content was sourced from clinicaltrials.gov