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

October 10, 2016 updated by: Pontificia Universidad Catolica de Chile

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Magallanes
      • Punta Arenas, Magallanes, Chile
        • Hospital de Punta Arenas
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Pontificia Universidad Catolica de Chile
    • VIII Región
      • Talcahuano, VIII Región, Chile
        • Hospital Las Higueras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5600 IU Vitamin D3
Oral 5600 IU Vitamin D3 in liquid weekly during 6 months
Dietary supplement: Vitamin D3
Cholecalciferol administration
Other Names:
  • Cholecalciferol
Experimental: Oral 11200 IU Vitamin D3 weekly
Oral 11200 IU Vitamin D3 in liquid weekly during 6 months
Dietary supplement: Vitamin D3
Cholecalciferol administration
Other Names:
  • Cholecalciferol
Placebo Comparator: Placebo
Oral placebo in liquid weekly during 6 months
Dietary supplement: Placebo
Placebo liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute respiratory tract infections
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

National Fund for Research and Development in Health, Chile
Laboratorio Pasteur

Investigators

  • Study Director: Arturo Borzutzky, M.D., Pontificia Universidad Catolica de Chile
  • Principal Investigator: María L Reyes, M.D., Pontificia Universidad Catolica de Chile
  • Study Director: Cecilia Vizcaya, M.D., Pontificia Universidad Catolica de Chile
  • Study Director: Catalina Le Roy, M.D., Pontificia Universidad Catolica de Chile
  • Study Director: Carlos A. Camargo Jr., M.D. Dr.PH., Massachusetts General Hospital, Harvard University
  • Study Director: Karin Brikmann, M.D., Hospital Regional de Punta Arenas
  • Study Director: Flavia Chamorro, M.D., Hospital de Coyhaique
  • Study Director: Marco Reyes, M.D., Hospital de Coyhaique
  • Study Director: Carolina Loureiro, M.D., Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-116
  • Fonis SA13I20173 (Other Grant/Funding Number: Fondo Nacional de Investigación y Desarrollo en Salud)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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