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Prevention study for Asthma in Children
Official title High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children
ClinicalTrials.gov ID: NCT05043116
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 71
You may be able to join if
- 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...
You likely can't join if
- 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 /...
- 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.
See the full eligibility 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...
- 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...
- 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...
- The child is being treated with medication that alters calcium or vitamin D absorption / metabolism.
The study team makes the final eligibility decision.
Where it's taking place
- Gentofte Municipality, Gentofte, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 71 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gentofte Municipality, Gentofte, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.