RecruitingPhase 2NCT05043116

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


Sponsor

Copenhagen Studies on Asthma in Childhood

Enrollment

320 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 MonthsMax Age: 71 Months

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving high-dose vitamin D supplements to young children (ages 1–5) who are admitted to the hospital with acute asthma-like breathing episodes can prevent future episodes. **You may be eligible if...** - Your child is between 1 and 5 years old - Your child has been admitted to a pediatric ward for an acute asthma-like episode with coughing, wheezing, or breathing difficulty - Your child is receiving or has received short-acting inhaled bronchodilators (SABA) as part of treatment, with or without inhaled corticosteroids **You may NOT be eligible if...** - Your child was admitted with pneumonia - Your child is already taking more than 400 IU of vitamin D per day - Your child has a condition where vitamin D supplementation would be unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTCholecalciferol D3

2000 IU of Vitamin D provided as oral suspension for one year

OTHEROral placebo suspension

Oral suspension with no active substance tasting like the active supplement.


Locations(1)

University Hospital of Copenhagen

Gentofte Municipality, Gentofte, Denmark

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NCT05043116


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