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NCT05043116RecruitingPhase 2

High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
320 (estimated)
First submitted
21 May 2021
Start date
Oct 2022
Primary completion date
Oct 2028
Lead sponsor
Copenhagen Studies on Asthma in Childhood
Diseases
Asthma
NCT number
NCT05043116

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 320
  • From Oct 2022 to the primary completion date, Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • The child has other chronic lung diseases.

Lab values

  • 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.

Age

  • 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 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.

Other

  • The child is hospitalized with pneumonia
  • The child's daily intake of vitamin D supplementation is\> 400 IU / day (\~ 10 μg / day).
  • The baby has been exclusively breastfed for the past 6 months.
  • The child is a newly arrived refugee or immigrant from regions with a high risk of rickets.

Who the study is looking for

  • 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

Age in the registry: 12 months to 71 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Copenhagen
Coordinator of this site? Confirm its status
Gentofte MunicipalityDenmarkRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.