Common ColdPhase 2NCT04368520
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection
A Phase 2 study testing Vitamin D3 in people with Common Cold, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2020to 1 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD)
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.
- Conditions
- Common Cold
- Being tested
- Vitamin D3, Placebo
- Keywords
- Rhinovirus
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
Vitamin D3Dietary supplement
3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
PlaceboOther
Hypromellose capsules, given daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Low dose vitamin D3 | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 |
| High dose vitamin D3 | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinovirus titres
PCR-detected rhinovirus-16 load sampled from the nasal mucosa
Measured: +3 to +5 days after inoculation
Secondary outcomes (3)
Respiratory symptom score (Jackson Score)
Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)
Measured: +1 to +14 days after inoculation
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)
Measured: Day 0 and +4 days after inoculation
Change in level of vitamin D-regulated gene expression
Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA
Measured: Day 0 and +4 days after inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Why it stopped: COVID-19 pandemic prevented start-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two treatment arms of vitamin D3: low dose (800IU) vs. high dose (3,200IU) given daily, for 3 months
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368520
- Sponsor's protocol ID
- COLDstudy
- Status last verified
- Jul 2024
- First submitted
- 26 Mar 2020
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD)
- ClinicalTrials.gov ID
- NCT04368520
- Acronym / sponsor ID
- COLDstudy
- Conditions
- Common Cold
- Keywords
- Rhinovirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemic prevented start-up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Two treatment arms of vitamin D3: low dose (800IU) vs. high dose (3,200IU) given daily, for 3 months
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Low dose vitamin D3 | Experimental | Dietary Supplement: Vitamin D3 |
| High dose vitamin D3 | Experimental | Dietary Supplement: Vitamin D3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months | Dietary supplement | Low dose vitamin D3 |
| Vitamin D33,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months | Dietary supplement | High dose vitamin D3 |
| PlaceboHypromellose capsules, given daily for 3 months | Other | Placebo |
Primary outcome
Rhinovirus titres
Time frame: +3 to +5 days after inoculation
PCR-detected rhinovirus-16 load sampled from the nasal mucosa
3 secondary outcomes
Respiratory symptom score (Jackson Score)
Time frame: +1 to +14 days after inoculation
Cytokine and chemokine concentrations
Time frame: Day 0 and +4 days after inoculation
Change in level of vitamin D-regulated gene expression
Time frame: Day 0 and +4 days after inoculation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Common Cold, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinovirus titres (time frame: +3 to +5 days after inoculation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.