Cholecalciferol Intervention to Prevent Respiratory Infections Study (CIPRIS)
|Respiratory Tract Infection Vitamin D Deficiency||Dietary Supplement: Cholecalciferol Dietary Supplement: Placebo||Phase 2|
|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|
- 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.
- 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
|Study Start Date:||May 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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
Dietary Supplement: Placebo
Microcellulose capsule identical in appearance to treatment
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549938
|Menzies Research Institute Tasmania|
|Hobart, Tasmania, Australia, 7000|
|Principal Investigator:||Steve Simpson, Jr., PhD, MPH||Menzies Institute for Medical Research|