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Cholecalciferol Intervention to Prevent Respiratory Infections Study (CIPRIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549938
First Posted: March 9, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Royal Hobart Hospital Research Foundation (funding source)
Information provided by (Responsible Party):
Dr Steve Simpson, Jr., Menzies Research Institute Tasmania
  Purpose
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.

Condition Intervention Phase
Respiratory Tract Infection Vitamin D Deficiency Dietary Supplement: Cholecalciferol Dietary Supplement: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Dr Steve Simpson, Jr., Menzies Research Institute Tasmania:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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


Enrollment: 32
Study Start Date: May 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
20,000 IU cholecalciferol capsule
Dietary Supplement: Cholecalciferol
20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
Placebo Comparator: Placebo
Microcellulose capsule
Dietary Supplement: Placebo
Microcellulose capsule identical in appearance to treatment

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549938


Locations
Australia, Tasmania
Menzies Research Institute Tasmania
Hobart, Tasmania, Australia, 7000
Sponsors and Collaborators
Menzies Institute for Medical Research
Royal Hobart Hospital Research Foundation (funding source)
Investigators
Principal Investigator: Steve Simpson, Jr., PhD, MPH Menzies Institute for Medical Research
  More Information

Responsible Party: Dr Steve Simpson, Jr., Postdoctoral Research Associate, Menzies Research Institute Tasmania
ClinicalTrials.gov Identifier: NCT01549938     History of Changes
Other Study ID Numbers: CIPRIS
ACTRN12612000054819 ( Registry Identifier: Australia and New Zealand Clinical Trials Registry )
U1111-1126-9425 ( Registry Identifier: World Health Organisation Universal Trial Number )
First Submitted: March 7, 2012
First Posted: March 9, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2012

Keywords provided by Dr Steve Simpson, Jr., Menzies Research Institute Tasmania:
Vitamin D
Cholecalciferol
Respiratory tract infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Vitamin D Deficiency
Respiratory Tract Infections
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Respiratory Tract Diseases
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents