WithdrawnPhase 2

Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

Stopped: COVID-19 pandemic prevented start-up

United Kingdom0Started 2020-03-01

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Age 18-70 years
✓. Gives written informed consent
✓. Serum 25-hydroxyvitamin D concentration \<75 nmol/L
✓. Agrees not to take supplement containing vitamin D during participation
✓. Agrees not to commence smoking or vaping during participation

Exclusion criteria

✕. Current smoker or vaper
✕. Taken vitamin D supplement or other supplement containing vitamin D, in previous 3 months
✕. Sunny holiday abroadI, defined as any location 51 degrees North/South of the equator, for ≥1 week, in the previous 3 months
✕. Dependent(s) \<6 months old
✕. Positive serology for anti-RV16 antibodies
✕. Living with someone with severe airways disease
✕. Any of the following medical conditions:
✕. Diabetes mellitus

What they're measuring

Rhinovirus titres

Timeframe: +3 to +5 days after inoculation

Trial details

NCT IDNCT04368520

SponsorQueen Mary University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

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