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.
None
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.
Parallel
Cholecalciferol D3
Dietary supplement2000 IU of Vitamin D provided as oral suspension for one year
Oral placebo suspension
Other interventionOral suspension with no active substance tasting like the active supplement.
Number of acute exacerbations
The primary objective of this double-blind, randomized, controlled clinical trial is to determine whether an oral daily dose of 2000 IU (\~ 50 μg) of vitamin D administered for a total of 12 months versus placebo leads to: Decrease in the number of acute exacerbations with asthma-like symptoms that require treatment with OCS and / or lead to hospitalization / treatment at a pediatric clinic. This in children aged 1-5 years with a medical history with asthma-like symptoms, and is in or has received treatment with SABA as monotherapy, or in combination ICS and possibly also LTRA.
Intervention with vitamin D versus placebo, time to first acute exacerbation
Change in time (days) to first acute exacerbation with asthma-like symptoms requiring OCS and / or hospitalization / treatment at a pediatric ward.
Intervention with vitamin D versus placebo, duration of symptoms
Change of the duration (days) of symptoms / hospitalization.
Intervention with vitamin D versus placebo, need for medical treatment
Change in the need for medical treatment during exacerbations, including SABA, short-acting anticholinergic inhalations (SAMA) and OCS.
Intervention with vitamin D versus placebo, daily symptom burden
Change in the daily symptom burden between exacerbations.
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