Actively Recruiting

Phase 2
Age: 12Months - 71Months
All Genders
NCT05043116

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

Led by Copenhagen Studies on Asthma in Childhood · Updated on 2025-04-16

320

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Months - 71Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1 to 5 years admitted to a pediatric ward due to an acute episode with asthma-like symptoms requiring hospitalization
  • Presence of symptoms such as coughing, wheezing, or difficulty breathing affecting the child's well-being
  • Current or recent treatment with short-acting beta-agonists (SABA) alone or combined with inhaled corticosteroids (ICS) and possibly leukotriene receptor antagonists (LTRA) according to Danish guidelines
Not Eligible

You will not qualify if you...

  • Hospitalization due to pneumonia
  • Daily vitamin D supplementation exceeding 400 IU (about 10 micrograms)
  • Use of vitamin and dietary supplements containing vitamin D exceeding 2400 IU per day for children aged 1-4 years
  • Exclusive breastfeeding for the past 6 months
  • Malnutrition defined as BMI or weight/height below the 3rd percentile according to age
  • Newly arrived refugees or immigrants from areas with a high risk of rickets
  • Presence of other chronic lung diseases
  • Diagnosed conditions such as impaired kidney function, neurological or psychiatric disorders, heart rhythm problems, severe heart failure, or liver impairment
  • Treatment with medications that affect calcium or vitamin D absorption or metabolism

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital of Copenhagen

Gentofte Municipality, Gentofte, Denmark, 2820

Actively Recruiting

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Research Team

K

Klaus Bønnelykke, MD, PhD

CONTACT

U

Ulrik Ralfkiaer, MSc, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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