Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Hypromellose capsules, given daily for 3 months

Low dose vitamin D3

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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

High dose vitamin D3

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

Interventions

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Vitamin D3

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

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Hypromellose capsules, given daily for 3 months

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes