Cholecalciferol Intervention to Prevent Respiratory Infections Study (CIPRIS)

This study has been completed.
Sponsor:
Collaborator:
Royal Hobart Hospital Research Foundation (funding source)
Information provided by (Responsible Party):
Dr Steve Simpson, Jr., Menzies Research Institute Tasmania
ClinicalTrials.gov Identifier:
NCT01549938
First received: March 7, 2012
Last updated: October 17, 2012
Last verified: October 2012

March 7, 2012
October 17, 2012
May 2012
October 2012   (final data collection date for primary outcome measure)
Frequency of validated respiratory tract infections during study period [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01549938 on ClinicalTrials.gov Archive Site
  • Proportion of colonisations leading to symptomatic respiratory tract infections [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    Proportion of colonisations with respiratory pathogens that go on to symptomatic verified respiratory tract infections. Colonisation detected by nasal swab sampled quantitiative RT-PCR.
  • Severity of respiratory tract infections during study [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    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.
  • Mean duration of respiratory tract infections during study [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    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.
  • Frequency of non-respiratory tract infections during study [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    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.
  • Concentration of serum 25-hydroxyvitamin D by the end of the study [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    Concentration of serum 25-hydroxyvitamin D by the end of the study
Same as current
Not Provided
Not Provided
 
Cholecalciferol Intervention to Prevent Respiratory Infections Study
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

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.

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

  1. Among persons with detected viral colonisations of the nasopharynx, treated persons will have a lower frequency of symptomatic respiratory tract infection resultant than controls.
  2. Treated group will have significantly less severe symptomatic RTIs than controls.
  3. 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Respiratory Tract Infection
  • Vitamin D Deficiency
  • Dietary Supplement: Cholecalciferol
    20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
  • Dietary Supplement: Placebo
    Microcellulose capsule identical in appearance to treatment
  • Active Comparator: Treatment
    20,000 IU cholecalciferol capsule
    Intervention: Dietary Supplement: Cholecalciferol
  • Placebo Comparator: Placebo
    Microcellulose capsule
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01549938
CIPRIS, ACTRN12612000054819, U1111-1126-9425
Yes
Dr Steve Simpson, Jr., Menzies Research Institute Tasmania
Menzies Research Institute Tasmania
Royal Hobart Hospital Research Foundation (funding source)
Principal Investigator: Steve Simpson, Jr., PhD, MPH Menzies Research Institute Tasmania
Menzies Research Institute Tasmania
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP