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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02046577

Enrollment

276

Registered

2014-01-28

Start date

2014-02-28

Completion date

2016-05-31

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Tract Infections

Keywords

Acute respiratory tract infections, vitamin D, cholecalciferol, children, bronchiolitis, pneumonia, prevention

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

Cholecalciferol administration

DIETARY_SUPPLEMENTPlacebo

Placebo liquid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Months to 36 Months

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Incidence of acute respiratory tract infections	6 months

Secondary

Measure	Time frame	Description
Adverse events	6 months	—
Hospitalizations due to acute respiratory tract infections	6 months	—
Viral etiology of ARTIs	6 months	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.
serum 25-hydroxyvitamin D levels	6 months	Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels.
Bone metabolism parameters	6 months	Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio.
Serum cathelicidin levels	6 months	Baseline and after 6 months measurement of serum cathelicidin levels.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026