NCT01549938

Cholecalciferol Intervention to Prevent Respiratory Infections Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Menzies Institute for Medical Research · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Respiratory Tract Infection
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
DIETARY_SUPPLEMENT	Placebo	Microcellulose capsule identical in appearance to treatment

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-10-01
• First posted: 2012-03-09
• Last updated: 2012-10-19

Locations

1 site across 1 country: Australia