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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children (NCT05043116) is a Phase 2 interventional studying Asthma in Children, sponsored by Copenhagen Studies on Asthma in Childhood. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Asthma in Children and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 320 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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 Exclusion Criteria: * 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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Cholecalciferol D3

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

OTHER

Oral placebo suspension

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospital of Copenhagen
Gentofte Municipality, Gentofte, Denmark

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05043116), the sponsor (Copenhagen Studies on Asthma in Childhood), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05043116 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05043116?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05043116?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05043116. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05043116. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.