NCT02046577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

January 23, 2014

Last Update Submit

October 10, 2016

Conditions

Acute Respiratory Tract Infections

Keywords

Acute respiratory tract infectionsvitamin Dcholecalciferolchildrenbronchiolitispneumoniaprevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute respiratory tract infections

    6 months

Secondary Outcomes (6)

  • Adverse events

    6 months

  • Hospitalizations due to acute respiratory tract infections

    6 months

  • Serum cathelicidin levels

    6 months

  • serum 25-hydroxyvitamin D levels

    6 months

  • Viral etiology of ARTIs

    6 months

  • +1 more secondary outcomes

Study Arms (3)

5600 IU Vitamin D3

EXPERIMENTAL

Oral 5600 IU Vitamin D3 in liquid weekly during 6 months

Dietary Supplement: Vitamin D3

Oral 11200 IU Vitamin D3 weekly

EXPERIMENTAL

Oral 11200 IU Vitamin D3 in liquid weekly during 6 months

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

Oral placebo in liquid weekly during 6 months

Dietary Supplement: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Cholecalciferol administration

Also known as: Cholecalciferol
5600 IU Vitamin D3Oral 11200 IU Vitamin D3 weekly
PlaceboDIETARY_SUPPLEMENT

Placebo liquid

Placebo

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 18 to 36 months attending daycare in Santiago, Coyhaique or Punta Arenas.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital de Punta Arenas

Punta Arenas, Region of Magallanes, Chile

Location

Hospital Las Higueras

Talcahuano, Región del Biobío, Chile

Location

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

BronchiolitisPneumonia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • María L Reyes, M.D.

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

  • Cecilia Vizcaya, M.D.

    Pontificia Universidad Catolica de Chile

    STUDY DIRECTOR

  • Arturo Borzutzky, 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 28, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

CL(3)