NCT02046577

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 18 Months – 36 Months
• Healthy volunteers: Accepted

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.

Conditions

• Acute Respiratory Tract Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3	Cholecalciferol administration
DIETARY_SUPPLEMENT	Placebo	Placebo liquid

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-12-01
• Completion: 2016-05-01
• First posted: 2014-01-28
• Last updated: 2016-10-12

Locations

3 sites across 1 country: Chile