Cholecalciferol Intervention to Prevent Respiratory Infections Study

Vitamin D Deficiency Clinical Trial

— CIPRIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549938
• Other study ID #: CIPRIS
• Secondary ID: ACTRN12612000054
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2012
• Last updated: October 17, 2012
• Start date: May 2012

Study information

• Verified date: October 2012
• Source: Menzies Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infection
• Respiratory Tract Infections
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Cholecalciferol
20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
• Placebo
Microcellulose capsule identical in appearance to treatment

Locations

Country	Name	City	State
Australia	Menzies Research Institute Tasmania	Hobart	Tasmania

Sponsors (2)

Lead Sponsor	Collaborator
Menzies Institute for Medical Research	Royal Hobart Hospital Research Foundation (funding source)

Country where clinical trial is conducted

Australia, 

Outcome

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