Cholecalciferol Intervention to Prevent Respiratory Infections Study (CIPRIS)
This study has been completed.
Sponsor:
Menzies Research Institute Tasmania
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:
MedlinePlus related topics:
Vitamin D
Drug Information available for:
Cholecalciferol
U.S. FDA Resources
Further study details as provided by Menzies Research Institute Tasmania:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| 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
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549938
Locations
| Australia, Tasmania | |
| Menzies Research Institute Tasmania | |
| Hobart, Tasmania, Australia, 7000 | |
Sponsors and Collaborators
Menzies Research Institute Tasmania
Royal Hobart Hospital Research Foundation (funding source)
Investigators
| Principal Investigator: | Steve Simpson, Jr., PhD, MPH | Menzies Research Institute Tasmania |
More Information
Additional Information:
No publications provided
| 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, U1111-1126-9425 |
| Study First Received: | March 7, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Menzies Research Institute Tasmania:
|
Vitamin D Cholecalciferol Respiratory tract infection |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Vitamin D Deficiency Infection Respiratory Tract Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Cholecalciferol Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 21, 2013