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

Phase 2

Completed

• Conditions: Acute Respiratory Tract Infections
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

• Registration Number: NCT02046577
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-28
• Study Start: 2014-02
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5600 IU Vitamin D3	Vitamin D3	Oral 5600 IU Vitamin D3 in liquid weekly during 6 months
Oral 11200 IU Vitamin D3 weekly	Vitamin D3	Oral 11200 IU Vitamin D3 in liquid weekly during 6 months
Placebo	Placebo	Oral placebo in liquid weekly during 6 months

Primary Outcome Measures

Name	Time	Method
Incidence of acute respiratory tract infections	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hospital Las Higueras; 🇨🇱 Talcahuano, VIII Región, Chile

Hospital de Punta Arenas; 🇨🇱 Punta Arenas, Magallanes, Chile

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile