Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

NCT04368520 | Withdrawn Phase 2

• 1 other identifier: COLDstudy
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rhinovirus

Outcome Measures

Primary Outcomes (1)

• Rhinovirus titres

  PCR-detected rhinovirus-16 load sampled from the nasal mucosa

  +3 to +5 days after inoculation

Secondary Outcomes (3)

• Respiratory symptom score (Jackson Score)

  +1 to +14 days after inoculation

• Cytokine and chemokine concentrations

  Day 0 and +4 days after inoculation

• Change in level of vitamin D-regulated gene expression

  Day 0 and +4 days after inoculation

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Low dose vitamin D3

EXPERIMENTAL

Dietary Supplement: Vitamin D3

High dose vitamin D3

EXPERIMENTAL

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

Low dose vitamin D3

Placebo OTHER

Hypromellose capsules, given daily for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Asthma
• Chronic Obstructive Pulmonary Disease
• Respiratory allergies
• Sarcoidosis
• Hyperparathyroidism
• Nephrolithiasis
• Active tuberculosis

Sponsors & Collaborators

• Queen Mary University of London: lead
• Imperial College London: collaborator

Study Sites (1)

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Common Cold

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two treatment arms of vitamin D3: low dose (800IU) vs. high dose (3,200IU) given daily, for 3 months

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 29, 2020
• Study Start: March 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 2 years after completion of the trial

Locations

GB (1)