Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04368520

Enrollment

Registered

2020-04-29

Start date

2020-03-01

Completion date

2022-05-01

Last updated

2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Cold

Keywords

Rhinovirus

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

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

OTHERPlacebo

Hypromellose capsules, given daily for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026