Vitamin D3
Dietary SupplementCholecalciferol administration
Other names: Cholecalciferol
NCT Number: NCT02046577
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.
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Notify Me18 month–36 month
All sexes
Interventional
Phase 2
Hospital Las Higueras, Talcahuano, Biobio, Chile
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cholecalciferol administration
Other names: Cholecalciferol
Placebo liquid
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Baseline and after 6 months measurement of serum cathelicidin levels.
Time frame: 6 months
Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels.
Time frame: 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.
Time frame: 6 months
Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio.
Pontificia Universidad Catolica de Chile
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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