NCT05043116 High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children
| NCT ID | NCT05043116 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Copenhagen Studies on Asthma in Childhood |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2028-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 320 participants in total. It began in 2022-10-01 with a primary completion date of 2028-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Bo Chawes, MD, DMSc
PRINCIPAL INVESTIGATOR
chawes@copsac.com
Frequently Asked Questions
Who can join the NCT05043116 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 71 Months, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05043116 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05043116 currently recruiting?
Yes, NCT05043116 is actively recruiting participants. Contact the research team at kb@copsac.com for enrollment information.
Where is the NCT05043116 trial being conducted?
This trial is being conducted at Gentofte Municipality, Denmark.
Who is sponsoring the NCT05043116 clinical trial?
NCT05043116 is sponsored by Copenhagen Studies on Asthma in Childhood. The principal investigator is Bo Chawes, MD, DMSc at chawes@copsac.com. The trial plans to enroll 320 participants.
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