Clinical trial NCT02046577: Study of Vitamin D for the Prevention of Acute Respiratory Infections in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Tract Infections
Keywords: Acute respiratory tract infections
vitamin D
cholecalciferol
children
bronchiolitis
pneumonia
prevention
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: National Fund for Research and Development in Health, Chile
name: Laboratorio Pasteur
First posted: 2014-01-28
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of acute respiratory tract infections
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events
timeFrame: 6 months
measure: Hospitalizations due to acute respiratory tract infections
timeFrame: 6 months
measure: Serum cathelicidin levels
timeFrame: 6 months
measure: serum 25-hydroxyvitamin D levels
timeFrame: 6 months
measure: Viral etiology of ARTIs
timeFrame: 6 months
measure: Bone metabolism parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Punta Arenas
country: Chile
facility: Hospital de Punta Arenas
state: Magallanes
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
state: Región Metropolitana
city: Talcahuano
country: Chile
facility: Hospital Las Higueras
state: VIII Región
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: María L Reyes, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Catolica de Chile
name: Cecilia Vizcaya, M.D.
role: STUDY_DIRECTOR
affiliation: Pontificia Universidad Catolica de Chile
name: Arturo Borzutzky, M.D.
role: STUDY_DIRECTOR
affiliation: Pontificia Universidad Catolica de Chile
name: Catalina Le Roy, M.D.
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital, Harvard University
name: Carlos A. Camargo Jr., M.D. Dr.PH.
role: STUDY_DIRECTOR
affiliation: Hospital Regional de Punta Arenas
name: Karin Brikmann, M.D.
role: STUDY_DIRECTOR
affiliation: Hospital de Coyhaique
name: Flavia Chamorro, M.D.
role: STUDY_DIRECTOR
affiliation: Hospital de Coyhaique
name: Marco Reyes, M.D.
role: STUDY_DIRECTOR
affiliation: Pontificia Universidad Catolica de Chile
name: Carolina Loureiro, M.D.
role: STUDY_DIRECTOR
References: