High-dose Vitamin D to prevent asthma-like symptoms in young children
High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children - a Double-blind, Randomized, Controlled Trial
This study is testing if giving high doses of vitamin D can help prevent asthma-like symptoms in young children aged 1-5 who often struggle with coughing and wheezing.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 12 Months to 71 Months |
| Sex | All |
| Sponsor | Copenhagen Studies on Asthma in Childhood Academic / other |
| Locations | 1 site (Gentofte Municipality, Gentofte) |
| Trial ID | NCT05043116 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preschool children aged 1-5 years who have been hospitalized due to acute asthma-like symptoms.
Not a fit: Patients hospitalized with pneumonia or those exceeding the daily recommended intake of vitamin D will not benefit from this study.
Why it matters
Potential benefit: If successful, this could significantly reduce the frequency of asthma-like symptoms and hospital visits in preschool children.
How similar studies have performed: Other studies have shown promising results with vitamin D supplementation in respiratory conditions, but this specific approach in preschool children is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gentofte Municipality, Gentofte
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.