Cholecalciferol Intervention to Prevent Respiratory Infections Study
NCT ID: NCT01549938
Last Updated: 2012-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
20,000 IU cholecalciferol capsule
Cholecalciferol
20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
Placebo
Microcellulose capsule
Placebo
Microcellulose capsule identical in appearance to treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cholecalciferol
20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
Placebo
Microcellulose capsule identical in appearance to treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Hobart Hospital Research Foundation (funding source)
UNKNOWN
Menzies Institute for Medical Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Steve Simpson, Jr.
Postdoctoral Research Associate
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steve Simpson, Jr., PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Menzies Institute for Medical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Menzies Research Institute Tasmania
Hobart, Tasmania, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACTRN12612000054819
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1126-9425
Identifier Type: REGISTRY
Identifier Source: secondary_id
CIPRIS
Identifier Type: -
Identifier Source: org_study_id