AzTrials
AzTrials

Acute Respiratory Tract InfectionsPhase 2NCT02046577

Study of Vitamin D for the Prevention of Acute Respiratory Infections in Children

A Phase 2 study testing Vitamin D3 in people with Acute Respiratory Tract Infections, run by Pontificia Universidad Catolica de Chile at 3 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to determine whether weekly oral vitamin D supplementation is effective to prevent acute respiratory tract infections in children. The hypothesis of the study is that vitamin D supplementation reduces the incidence and severity of acute respiratory tract infections in children. Read more about this study

Who is it for?
Ages 18 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Acute Respiratory Tract Infections
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
3 sitesChile
Study dates
Feb 2014to May 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 18 to 36 months attending daycare in Santiago, Coyhaique or Punta Arenas.

Who cannot join

  • History of chronic illness requiring immunosuppression
  • History of metabolic bone disease
  • Use of vitamin D supplementation greater than 400 IU daily, either by milk formula or vitamin supplements in the last 3 months.
  • Use of fish oil supplements in the last 3 months.
  • Immunodeficiency
  • Planned trip to sunny climate during study period.

Trial locations and contacts

3 sites in 1 country.

Chile3 sites

  • Hospital de Punta Arenas

    Punta Arenas, Region of Magallanes

  • Pontificia Universidad Católica de Chile

    Santiago, Santiago Metropolitan

  • Hospital Las Higueras

    Talcahuano, Biobio

Other trials in Chile

About this study

Official title: A Randomized, Double-blind, Controlled Trial of Vitamin D for the Prevention of Acute Respiratory Infections in Children Aged 18 to 36 Months in Santiago, Coyhaique and Punta Arenas, Chile

The main purpose of this study is to determine whether weekly oral vitamin D supplementation is effective to prevent acute respiratory tract infections in children. The hypothesis of the study is that vitamin D supplementation reduces the incidence and severity of acute respiratory tract infections in children.

Read the detailed description

Acute respiratory tract infections (ARTIs) are associated with high levels of morbidity and socioeconomic impact, particularly affecting young children. Observational studies have shown an association between vitamin D (VD) deficiency and higher incidence and severity of respiratory infections. Chile has a high prevalence of VD deficiency, particularly in the southern regions of the country. The objective of this study is to evaluate the safety and efficacy of oral VD supplementation to decrease the incidence of ARTIs in 275 preschool children. A randomized, placebo-controlled, double-blind study will be performed in Santiago, Coyhaique and Punta Arenas. Children aged 18 to 36 months will be given weekly oral 5600 IU of vitamin D3 (VD3), 11200 IU of VD3, or placebo doses during 6 months.

Being tested
Vitamin D3, Placebo
Keywords
Acute respiratory tract infections, vitamin D, cholecalciferol, children, bronchiolitis, pneumonia, prevention
Medical subject headings
Bronchiolitis, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Dietary supplement

    Also called Cholecalciferol

    Cholecalciferol administration

  • PlaceboDietary supplement

    Placebo liquid

Study groups in NCT02046577
Study groupRoleWhat they receive
5600 IU Vitamin D3ExperimentalOral 5600 IU Vitamin D3 in liquid weekly during 6 months
Receives: Dietary Supplement: Vitamin D3
Oral 11200 IU Vitamin D3 weeklyExperimentalOral 11200 IU Vitamin D3 in liquid weekly during 6 months
Receives: Dietary Supplement: Vitamin D3
PlaceboPlacebo comparatorOral placebo in liquid weekly during 6 months
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute respiratory tract infections

    Measured: 6 months

Secondary outcomes (6)

  1. Adverse events

    Measured: 6 months

  2. Hospitalizations due to acute respiratory tract infections

    Measured: 6 months

  3. Serum cathelicidin levels

    Baseline and after 6 months measurement of serum cathelicidin levels.

    Measured: 6 months

  4. serum 25-hydroxyvitamin D levels

    Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels.

    Measured: 6 months

  5. Viral etiology of ARTIs

    Specific virological etiology of ARTIs will be evaluated by polymerase chain reaction in children with febrile ARTIs and with medical diagnosis of bronchiolitis or pneumonia.

    Measured: 6 months

  6. Bone metabolism parameters

    Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02046577
Sponsor's protocol ID
13-116
Other IDs
Fonis SA13I20173
Status last verified
Oct 2016
First submitted
23 Jan 2014
Last updated
12 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Reyes ML, Vizcaya C, Le Roy C, Loureiro C, Brinkmann K, Arancibia M, Campos L, Iturriaga C, Perez-Mateluna G, Rojas-McKenzie M, Dominguez G, Camargo CA Jr, Borzutzky A. Weekly Vitamin D Supplementation to Prevent Acute Respiratory Infections in Young Children at Different Latitudes: A Randomized Controlled Trial. J Pediatr. 2024 Dec;275:114249. doi: 10.1016/j.jpeds.2024.114249. Epub 2024 Aug 22.

    PubMed 39181322

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D3 in people with Acute Respiratory Tract Infections, run by Pontificia Universidad Catolica de Chile at 3 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute respiratory tract infections (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02046577, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in