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Completed

NCT Number: NCT01549938

Cholecalciferol Intervention to Prevent Respiratory Infections Study

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Menzies Research Institute Tasmania

Hobart, Tasmania, 7000, Australia

About this study

The hypotheses of the full study are:

Primary The group treated with vitamin D3 will have a significantly lower frequency of symptomatic respiratory tract infections than controls.

Secondary

  • Among persons with detected viral colonisations of the nasopharynx, treated persons will have a lower frequency of symptomatic respiratory tract infection resultant than controls.
  • Treated group will have significantly less severe symptomatic RTIs than controls.
  • Treated group will have significantly shorter symptomatic RTI durations than controls.

For the pilot, a cohort of 32 healthy young adults satisfying inclusion criteria will be randomised to cholecalciferol supplement or identical placebo and evaluated daily for the occurrence of RTI symptoms and evaluated weekly for the presence of respiratory colonisation by relevant pathogens using nasopharyngeal swab and polymerase chain reaction using selected pathogen-specific primers. This pilot will demonstrate the logistic feasibility of the proposed study design and provide preliminary data which will inform a larger study to be undertaken next year.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Cholecalciferol

Dietary Supplement

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

Placebo

Dietary Supplement

Microcellulose capsule identical in appearance to treatment

Primary outcomes

  1. Frequency of validated respiratory tract infections during study period

    Time frame: 17 weeks

    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.

Secondary outcomes

  1. Proportion of colonisations leading to symptomatic respiratory tract infections

    Time frame: 17 weeks

    Proportion of colonisations with respiratory pathogens that go on to symptomatic verified respiratory tract infections. Colonisation detected by nasal swab sampled quantitiative RT-PCR.

  2. Severity of respiratory tract infections during study

    Time frame: 17 weeks

    Severity (objective and subjective) of respiratory tract infections during the study. Subjective severity of symptoms reported by Likert scale (0-5) for each symptom. Objective severity by number and duration of symptoms.

  3. Mean duration of respiratory tract infections during study

    Time frame: 17 weeks

    Mean duration of respiratory tract infections during study. Duration defined as number of days from participant-reported symptom onset to sympton resolution, as reported in daily online questionnaire.

  4. Frequency of non-respiratory tract infections during study

    Time frame: 17 weeks

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

  5. Concentration of serum 25-hydroxyvitamin D by the end of the study

    Time frame: 17 weeks

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

Sponsors and collaborators

Lead sponsor

Menzies Institute for Medical Research

Other

Collaborators

  • Royal Hobart Hospital Research Foundation (funding source)

Registry information

Official study title

Cholecalciferol Intervention to Prevent Respiratory Infections Study: a Double-blind Randomised Controlled Trial to Evaluate the Efficacy of 20,000 IU/wk Cholecalciferol in Reducing Respiratory Tract Infection in a Cohort of Healthy Young Adults

Acronym: CIPRIS

Important dates

Study start
2012
Primary completion
2012
First posted
Mar 9, 2012
Registry last updated
Oct 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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