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

NCT05043116 | Recruiting Phase 2

• 1 other identifier: H-20066827
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Keywords

Wheeze; Infections; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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.

  One year

Secondary Outcomes (32)

• Intervention with vitamin D versus placebo, time to first acute exacerbation

  One year

• Intervention with vitamin D versus placebo, duration of symptoms

  One year

• Intervention with vitamin D versus placebo, need for medical treatment

  One year

• Intervention with vitamin D versus placebo, daily symptom burden

  One year

• Intervention with vitamin D versus placebo, step-down of preventive treatment

  One year

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Dietary supplement: 2000 IU Vitamin D3 daily dose (oral suspension) for one year.

Dietary Supplement: Cholecalciferol D3

Placebo

PLACEBO COMPARATOR

Oral suspension with no active substance, identical to the active suspension for one year.

Other: Oral placebo suspension

Interventions

Cholecalciferol D3 DIETARY_SUPPLEMENT

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

Also known as: Vitamin D from Apovit, Denmark

Vitamin D

Oral placebo suspension OTHER

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

Placebo

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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. 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

You may not qualify 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 / 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.
• 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 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.

Sponsors & Collaborators

• Copenhagen Studies on Asthma in Childhood: lead

Study Sites (1)

University Hospital of Copenhagen

Gentofte Municipality, Gentofte, 2820, Denmark

RECRUITING

Related Publications (1)

• Kyvsgaard JN, Ralfkiaer U, Folsgaard N, Jensen TM, Hesselberg LM, Schoos AM, Bonnelykke K, Bisgaard H, Stokholm J, Chawes B. Azithromycin and high-dose vitamin D for treatment and prevention of asthma-like episodes in hospitalised preschool children: study protocol for a combined double-blind randomised controlled trial. BMJ Open. 2022 Apr 13;12(4):e054762. doi: 10.1136/bmjopen-2021-054762.

  PMID: 35418427 DERIVED

MeSH Terms

Conditions

Respiratory Sounds; Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo Chawes, MD, DMSc

  chawes@copsac.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Bønnelykke, MD, PhD

CONTACT

+4538677360; kb@copsac.com

Ulrik Ralfkiaer, MSc, PhD

CONTACT

+4538674164; administration@dbac.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: September 14, 2021
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 16, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)