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Cholecalciferol Intervention to Prevent Respiratory Infections Study

NCT01549938 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-10-19

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infection
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

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

DIETARY_SUPPLEMENT

Placebo

Microcellulose capsule identical in appearance to treatment

Sponsors & Collaborators

  • Royal Hobart Hospital Research Foundation (funding source)

    collaborator UNKNOWN

  • Menzies Institute for Medical Research

    lead OTHER

Principal Investigators

  • Steve Simpson, Jr., PhD, MPH · Menzies Institute for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-10-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549938 on ClinicalTrials.gov