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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
276
Cholecalciferol administration
Placebo liquid
Hospital Las Higueras
Talcahuano, Biobio, Chile
Hospital de Punta Arenas
Punta Arenas, Region of Magallanes, Chile
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, Chile
Incidence of acute respiratory tract infections
Time frame: 6 months
Adverse events
Time frame: 6 months
Hospitalizations due to acute respiratory tract infections
Time frame: 6 months
Serum cathelicidin levels
Baseline and after 6 months measurement of serum cathelicidin levels.
Time frame: 6 months
serum 25-hydroxyvitamin D levels
Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels.
Time frame: 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.
Time frame: 6 months
Bone metabolism parameters
Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio.
Time frame: 6 months
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