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

Acute Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046577
• Other study ID #: 13-116
• Secondary ID: Fonis SA13I20173
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2014
• Last updated: October 10, 2016
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y TecnológicaChile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 36 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Tract Infections
• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Vitamin D3
Cholecalciferol administration
• Placebo
Placebo liquid

Locations

Country	Name	City	State
Chile	Hospital de Punta Arenas	Punta Arenas	Magallanes
Chile	Pontificia Universidad Católica de Chile	Santiago	Región Metropolitana
Chile	Hospital Las Higueras	Talcahuano	VIII Región

Sponsors (3)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Fondo Nacional de Investigación y Desarrollo en Salud, Chile, Laboratorio Pasteur

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute respiratory tract infections		6 months	No
Secondary	Adverse events		6 months	No
Secondary	Hospitalizations due to acute respiratory tract infections		6 months	No
Secondary	Serum cathelicidin levels	Baseline and after 6 months measurement of serum cathelicidin levels.	6 months	No
Secondary	serum 25-hydroxyvitamin D levels	Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels.	6 months	No
Secondary	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	No
Secondary	Bone metabolism parameters	Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio.	6 months	Yes