Cholecalciferol Intervention to Prevent Respiratory Infections Study (CIPRIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Respiratory Tract Infection
• Intervention / Treatment: Dietary supplement: Cholecalciferol; Dietary supplement: Placebo

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

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Menzies Research Institute Tasmania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Menzies Institute for Medical Research
• Collaborators: Royal Hobart Hospital Research Foundation (funding source)
• Investigators: Principal Investigator: Steve Simpson, Jr., PhD, MPH, Menzies Institute for Medical Research

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 17, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Vitamin D; Cholecalciferol; Respiratory tract infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Infections; Communicable Diseases; Vitamin D Deficiency; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CIPRIS; ACTRN12612000054819 (Registry Identifier: Australia and New Zealand Clinical Trials Registry); U1111-1126-9425 (Registry Identifier: World Health Organisation Universal Trial Number)