Trials / Withdrawn
WithdrawnNCT04368520
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Queen Mary University of London · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin D3 | 800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months |
| DIETARY_SUPPLEMENT | Vitamin D3 | 3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months |
| OTHER | Placebo | Hypromellose capsules, given daily for 3 months |
Timeline
- Start date
- 2020-03-01
- Primary completion
- 2022-05-01
- Completion
- 2022-05-01
- First posted
- 2020-04-29
- Last updated
- 2024-07-05
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04368520. Inclusion in this directory is not an endorsement.