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Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

Primary Purpose

Common Cold

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Vitamin D3
Vitamin D3
Placebo
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Cold focused on measuring Rhinovirus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion criteria:

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

  7. Any of the following medical conditions:

    1. Diabetes mellitus
    2. Asthma
    3. Chronic Obstructive Pulmonary Disease
    4. Respiratory allergies
    5. Sarcoidosis
    6. Hyperparathyroidism
    7. Nephrolithiasis
    8. Active tuberculosis
    9. Liver failure
    10. Renal failure
    11. Lymphoma or other malignancy not in remission for ≥ 3 years

Sites / Locations

  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Low dose vitamin D3

High dose vitamin D3

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Respiratory symptom score (Jackson Score)
Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)
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)
Change in level of vitamin D-regulated gene expression
Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA

Full Information

First Posted
March 26, 2020
Last Updated
April 27, 2020
Sponsor
Queen Mary University of London
Collaborators
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT04368520
Brief Title
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection
Official Title
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Rhinovirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two treatment arms of vitamin D3: low dose (800IU) vs. high dose (3,200IU) given daily, for 3 months
Masking
Participant
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Low dose vitamin D3
Arm Type
Experimental
Arm Title
High dose vitamin D3
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Hypromellose capsules, given daily for 3 months
Primary Outcome Measure Information:
Title
Rhinovirus titres
Description
PCR-detected rhinovirus-16 load sampled from the nasal mucosa
Time Frame
+3 to +5 days after inoculation
Secondary Outcome Measure Information:
Title
Respiratory symptom score (Jackson Score)
Description
Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)
Time Frame
+1 to +14 days after inoculation
Title
Cytokine and chemokine concentrations
Description
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
Title
Change in level of vitamin D-regulated gene expression
Description
Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA
Time Frame
Day 0 and +4 days after inoculation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Asthma Chronic Obstructive Pulmonary Disease Respiratory allergies Sarcoidosis Hyperparathyroidism Nephrolithiasis Active tuberculosis Liver failure Renal failure Lymphoma or other malignancy not in remission for ≥ 3 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David A Jolliffe, PhD
Phone
07920648370
Email
d.a.jolliffe@qmul.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian R Martineau, PhD
Phone
0207 882 2551
Email
a.martineau@qmul.ac.uk
Facility Information:
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian L Johnston, PhD
Phone
020 7594 3764
Email
s.johnston@imperial.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
IPD Sharing Time Frame
2 years after completion of the trial

Learn more about this trial

Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

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