Vitamin D Deficiency Clinical Trial
— CIPRISOfficial 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
Verified date | October 2012 |
Source | Menzies Institute for Medical Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Australia | Menzies Research Institute Tasmania | Hobart | Tasmania |
Lead Sponsor | Collaborator |
---|---|
Menzies Institute for Medical Research | Royal Hobart Hospital Research Foundation (funding source) |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of validated respiratory tract infections during study period | 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. | 17 weeks | |
Secondary | Proportion of colonisations leading to symptomatic respiratory tract infections | Proportion of colonisations with respiratory pathogens that go on to symptomatic verified respiratory tract infections. Colonisation detected by nasal swab sampled quantitiative RT-PCR. | 17 weeks | |
Secondary | Severity of respiratory tract infections during study | 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. | 17 weeks | |
Secondary | Mean duration of respiratory tract infections during study | 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. | 17 weeks | |
Secondary | Frequency of non-respiratory tract infections during study | 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. | 17 weeks | |
Secondary | Concentration of serum 25-hydroxyvitamin D by the end of the study | Concentration of serum 25-hydroxyvitamin D by the end of the study | 17 weeks |
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