Respiratory Tract InfectionsNCT04596657
Vitamin D3 Supplementation to Prevent Respiratory Tract Infections
A study testing Vitamin D supplementation in people with Respiratory Tract Infections and Covid19, run by Cooper Norcross Health at 1 site in United States.
Trial summary
The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Covid19, Flu Like Illness
- What is being tested?
- Vitamin D supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 877 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 19 Oct 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospital worker
- Age 18 years or older
Who cannot join
- History of hypercalcemia
- History of nephrolithiasis
- History of intolerance to vitamin D3 supplements
- Use of calcium at a dose > 600 mg/day (individuals using a dose greater than 600 mg of calcium per day will be asked to limit the amount to 600 mg unless they have been directed by their physician to be taking more than 600 mg/day of calcium. If the latter is true the potential subject will be excluded from the study.)
- Use of vitamin D at a daily dose > 5000 IU*
- Use of aluminum-containing phosphate binders in patients with renal failure
Show all 27Show fewer
- Use of calcipotriene
- Use of digoxin
- Use of thiazide diuretics if using:
- hydrochlorothiazide at a daily dose > 37.5 mg
- indapamide at a daily dose > 1.25 mg
- chlorthalidone at a daily dose > 12.5 mg
- metolazone at a daily dose > 2.5 mg
- methyclothiazide at a daily dose > 2.5 mg
- chlorothiazide at a daily dose > 250 mg
- metolazone at a daily dose > 0.5 mg
- bendroflumethiazide at a daily dose > 2.5 mg
- polythiazide at a daily dose > 1 mg
- hydroflumethiazide at a daily dose > 25 mg
- Conditions that are associated with a risk of modified vitamin D metabolism
- Known allergy to wool
- Current enrollment in another study
- Life expectancy <1 month at time of screening
- Cognitive impairment precluding the ability to provide informed consent
- Pregnant or trying to become pregnant
- Employee is team member on the present study
- If potential participants are found to be using vitamin D supplementation upon screening at a daily dose ≤5000 IU/day, they will be eligible for participation by switching to the study dose. If potential participants are taking a multiple vitamin or calcium supplement and there is less than or equal to 800 IU vitamin D in it, they can continue the multivitamin or calcium supplement along with taking the study vitamin D3. Total vitamin D cannot exceed 5,800 IU per day combined between any supplements that contain vitamin D. Use of vitamin D at a daily dose > 5000 IU at the direction of a physician will be an exclusion criterion. If a potential subject uses over-the-counter vitamin D not directed by a physician at a daily dose > 5000 IU they will be eligible to participate by switching to the lower study dose.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
About this study
Official title: Vitamin D3 Supplementation to Prevent Respiratory Tract Infections, Including Covid-19, in Hospital Workers: a Pragmatic Study
The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers.
Read the detailed description
Influenza-like illness and covid-19 were added to this summary because the protocol uses respiratory tract infections and influenza-like illness interchangeably. Influenza-like illness is more accurate.
Protocol amendments:
Protocol title was amended to include covid-19. Minimum age was changed from 52 to 18, expanding the sample size. Exclusion criteria re vitamin D intake was changed from >5000 to >=5000 IU.
- Conditions
- Respiratory Tract Infections, Covid19, Flu Like Illness
- Being tested
- Vitamin D supplementation
- Medical subject headings
- Respiratory Tract Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementationDietary supplement
Daily vitamin D3 supplementation (5000 IU)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Dietary Supplement: Vitamin D supplementation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza-like illness
Incidence of influenza-like illness
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start27 Oct 2020
- Primary completion23 Nov 2021
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Collaborators
- Won Sook Chung Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596657
- Sponsor's protocol ID
- 20-455
- Status last verified
- Dec 2023
- First submitted
- 15 Oct 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Supplementation to Prevent Respiratory Tract Infections, Including Covid-19, in Hospital Workers: a Pragmatic Study
- ClinicalTrials.gov ID
- NCT04596657
- Acronym / sponsor ID
- 20-455
- Conditions
- Respiratory Tract Infections, Covid19, Flu Like Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 877 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Collaborators
- Won Sook Chung Foundation
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 22 Oct 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.
The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers.
Detailed description
Influenza-like illness and covid-19 were added to this summary because the protocol uses respiratory tract infections and influenza-like illness interchangeably. Influenza-like illness is more accurate.
Protocol amendments:
Protocol title was amended to include covid-19. Minimum age was changed from 52 to 18, expanding the sample size. Exclusion criteria re vitamin D intake was changed from >5000 to >=5000 IU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Vitamin D supplementation |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospital worker
- Age 18 years or older
Key exclusion criteria (27 listed)
- History of hypercalcemia
- History of nephrolithiasis
- History of intolerance to vitamin D3 supplements
- Use of calcium at a dose > 600 mg/day (individuals using a dose greater than 600 mg of calcium per day will be asked to limit the amount to 600 mg unless they have been directed by their physician to be taking more than 600 mg/day of calcium. If the latter is true the potential subject will be excluded from the study.)
- Use of vitamin D at a daily dose > 5000 IU*
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 D supplementationDaily vitamin D3 supplementation (5000 IU) | Dietary supplement | Intervention |
Primary outcome
Influenza-like illness
Time frame: 9 months
Incidence of influenza-like illness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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 study testing Vitamin D supplementation in people with Respiratory Tract Infections and Covid19, run by Cooper Norcross Health at 1 site in United States.
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 2 inclusion and 27 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: finished, as of the sponsor's last update on 8 Dec 2023. 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 States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Influenza-like illness (time frame: 9 months). 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 8 Dec 2023.