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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Respiratory Tract Infections

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5600 IU Vitamin D3<br>Oral 5600 IU Vitamin D3 in liquid weekly during 6 months | Dietary Supplement: Vitamin D3<br>* Cholecalciferol administration<br>* Other names: Cholecalciferol;|
| Experimental: Oral 11200 IU Vitamin D3 weekly<br>Oral 11200 IU Vitamin D3 in liquid weekly during 6 months | Dietary Supplement: Vitamin D3<br>* Cholecalciferol administration<br>* Other names: Cholecalciferol;|
| Placebo Comparator: Placebo<br>Oral placebo in liquid weekly during 6 months | Dietary Supplement: Placebo<br>* Placebo liquid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute respiratory tract infections |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute respiratory tract infections, vitamin D, cholecalciferol, children, bronchiolitis, pneumonia, prevention