NCT01549938

Brief Summary

This is a feasibility double-blind randomised controlled trial in 32 participants. It evaluates the feasibility of a full trial which will examine the efficacy of weekly supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent frequency and severity of objectively-verified symptomatic acute respiratory tract infection, overall and as a proportion of detected colonisations of the upper respiratory tract by 9 of the most common aetiologic viral pathogens.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

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

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

March 7, 2012

Last Update Submit

October 17, 2012

Conditions

Respiratory Tract InfectionVitamin D Deficiency

Keywords

Vitamin DCholecalciferolRespiratory tract infection

Outcome Measures

Primary Outcomes (1)

  • Frequency of validated respiratory tract infections during study period

    Frequency of validated respiratory tract infections during study period. Acute respiratory tract infections defined by respiratory symptoms reported by daily online survey lasting over a day and verified at exam by study nurse.

    17 weeks

Secondary Outcomes (5)

  • Proportion of colonisations leading to symptomatic respiratory tract infections

    17 weeks

  • Severity of respiratory tract infections during study

    17 weeks

  • Mean duration of respiratory tract infections during study

    17 weeks

  • Frequency of non-respiratory tract infections during study

    17 weeks

  • Concentration of serum 25-hydroxyvitamin D by the end of the study

    17 weeks

Study Arms (2)

Treatment

ACTIVE COMPARATOR

20,000 IU cholecalciferol capsule

Dietary Supplement: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Microcellulose capsule

Dietary Supplement: Placebo

Interventions

CholecalciferolDIETARY_SUPPLEMENT

20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.

Treatment
PlaceboDIETARY_SUPPLEMENT

Microcellulose capsule identical in appearance to treatment

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Students undertaking study at the MS1 building of University of Tasmania Medical Sciences Precinct (17 Liverpool St Hobart TAS) for the full duration between May and September 2012

You may not qualify if:

  • Persons who have used tobacco within the 6 months preceding study entry
  • Persons who have used any vitamin D (cholecalciferol or ergocalciferol) supplements or calcium supplements within the 3 months preceding study entry and/or persons who refuse to not start taking any such supplement during the study
  • Persons using any immunomodulatory medication, diuretic medication, antiepileptic medication, or barbiturates.
  • Persons who presently have been diagnosed with any chronic infectious disease (e.g. HIV, tuberculosis), chronic immune deficiency or autoimmune condition, or respiratory condition (e.g. asthma, chronic obstructive pulmonary disease).
  • Persons who are hypersensitive to vitamin D.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menzies Research Institute Tasmania

Hobart, Tasmania, 7000, Australia

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Steve Simpson, Jr., PhD, MPH

    Menzies Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Associate

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2012

Last Updated

October 19, 2012

Record last verified: 2012-10

Locations

AU(1)