Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

Phase 2

Withdrawn

• Conditions: Common Cold
• Interventions: Dietary Supplement: Vitamin D3; Other: Placebo

• Registration Number: NCT04368520
• Lead Sponsor: Queen Mary University of London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose vitamin D3	Vitamin D3	-
Placebo	Placebo	-
Low dose vitamin D3	Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
Rhinovirus titres	+3 to +5 days after inoculation	PCR-detected rhinovirus-16 load sampled from the nasal mucosa

Secondary Outcome Measures

Name	Time	Method
Respiratory symptom score (Jackson Score)	+1 to +14 days after inoculation	Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)
Cytokine and chemokine concentrations	Day 0 and +4 days after inoculation	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	Day 0 and +4 days after inoculation	Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA

Trial Locations

Locations (1)

St. Mary's Hospital; 🇬🇧 London, United Kingdom