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Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

NCT04368520 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-07-05

No results posted yet for this study

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

  • Common Cold

Interventions

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

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-05-01
Completion
2022-05-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368520 on ClinicalTrials.gov