Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

Common Cold Clinical Trial

Official title:

Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04368520
• Other study ID #: COLDstudy
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2020
• Est. completion date: May 2022

Study information

• Verified date: March 2020
• Source: Queen Mary University of London
• Contact: David A Jolliffe, PhD
• Phone: 07920648370
• Email: d.a.jolliffe[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 195
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold

Intervention

Dietary Supplement:
• Vitamin D3
800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
• Vitamin D3
3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

Other:
• Placebo
Hypromellose capsules, given daily for 3 months

Locations

Country	Name	City	State
United Kingdom	St. Mary's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinovirus titres	PCR-detected rhinovirus-16 load sampled from the nasal mucosa	+3 to +5 days after inoculation
Secondary	Respiratory symptom score (Jackson Score)	Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)	+1 to +14 days after inoculation
Secondary	Cytokine and chemokine concentrations	Change in concentrations of inflammatory mediators (Including, but not limited to IL-1ß, 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-a, IFN-?, TNF-a, MCP-1 [CCL2], MIP- 1a [CCL3], MIP-1ß [CCL4], RANTES [CCL5], eotaxin [CCL11], MIG [CXCL9], IP-10 [CXCL10], EGF, FGF-basic, HGF, VEGF, G-CSF, GM-CSF)	Day 0 and +4 days after inoculation
Secondary	Change in level of vitamin D-regulated gene expression	Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA	Day 0 and +4 days after inoculation