A phase II randomised, placebo-controlled trial to identify the optimal regimen of vitamin D supplementation for rhinovirus protection, determined by host responses to a clinically induced rhinovirus challenge. The primary outcome is rhinovirus titre after inoculation with rhinovirus; secondary outcomes are self-reported respiratory symptom scores, concentrations of cytokines and chemokines sampled from the nasal mucosa, and the transcriptional responses of nasal epithelial cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
Hypromellose capsules, given daily for 3 months
St. Mary's Hospital
London, United Kingdom
Rhinovirus titres
PCR-detected rhinovirus-16 load sampled from the nasal mucosa
Time frame: +3 to +5 days after inoculation
Respiratory symptom score (Jackson Score)
Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)
Time frame: +1 to +14 days after inoculation
Cytokine and chemokine concentrations
Change in concentrations of inflammatory mediators (Including, but not limited to IL-1β, IL-2, IL-4, IL-5, Il-6, IL- 7, IL-8 \[CXCL8\], IL-10, IL-12, IL-13, IL-15, IL-17, IL-1RA, IL-2R, IFN-α, IFN-γ, TNF-α, MCP-1 \[CCL2\], MIP- 1α \[CCL3\], MIP-1β \[CCL4\], RANTES \[CCL5\], eotaxin \[CCL11\], MIG \[CXCL9\], IP-10 \[CXCL10\], EGF, FGF-basic, HGF, VEGF, G-CSF, GM-CSF)
Time frame: Day 0 and +4 days after inoculation
Change in level of vitamin D-regulated gene expression
Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA
Time frame: Day 0 and +4 days after inoculation
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