Covid 19Phase 1NCT04407286
Vitamin D Testing and Treatment for COVID 19
A Phase 1 study testing Vitamin D3 in people with Covid 19 and Vitamin D Deficiency, run by Arizona State University at 1 site in United States.
Trial summary
This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid 19, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2020to 30 Nov 2020
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age 18 or older
- Previous positive test result for COVID 19
- Able to communicate clearly in English Exclusion Criteria for Part 1 (testing): none
- Participation in Part 1
- Vitamin D level below 30 ng/ml
- No abnormalities on the comprehensive metabolic panel that are clinically significant to increasing the risk of an adverse reaction to vitamin D supplementation
Who cannot join
- Liver impairment
- Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant.
- Pregnancy
- No symptoms for 2 weeks after positive COVID 19 test
- Recovered from symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Testing and Treatment for Adults With COVID 19
This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D.
Read the detailed description
Protocol for Part 1:
- A single blood draw at SCNM to measure levels of vitamin D and other nutrients, comprehensive metabolic panel, and complete blood count with differential
- Completing a medical history/symptom form
- Completing a form about COVID-19 symptoms every 2 weeks for 6 weeks
- Authorization for release of medical records related to COVID 19 testing and/or treatment.
Protocol for Part 2:
- Take a vitamin D supplement daily for two weeks, at a dosage of 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
- After two weeks of taking vitamin D, return to SCNM for a blood draw to remeasure levels of vitamin D, comprehensive metabolic panel, and complete blood count with differential. If vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.
- Completing questionnaires about COVID 19 symptoms at 2, 4, and 6 weeks after treatment begins (5 minutes each time).
- Conditions
- Covid 19, Vitamin D Deficiency
- Being tested
- Vitamin D3
- Medical subject headings
- COVID-19, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Oral vitamin D3 capsules
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group will receive vitamin D.
The dosage for the first two weeks will be 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
After two weeks of taking vitamin D, if vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D levels
change in level of Vitamin D, 25-Hydroxy between the two time points
Measured: baseline and after two weeks of vitamin D supplementation
severity of COVID 19 symptoms
We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation
Measured: baseline and at 2 weeks after vitamin D supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start19 May 2020
- Primary completion30 Aug 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19Studies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label treatment study for people with COVID 19 and low levels of vitamin D
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest College of Naturopathic Medicine
- Responsible party
- Sponsor
- Investigators
- James B Adams, PhD, Principal investigator, Arizona State UniversitySarah Trahan, NMD, Principal investigator, Southwest College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407286
- Sponsor's protocol ID
- STUDY00011960
- Status last verified
- Dec 2021
- First submitted
- 19 May 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contact us if you wish to discuss sharing of de-identified data
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Testing and Treatment for Adults With COVID 19
- ClinicalTrials.gov ID
- NCT04407286
- Acronym / sponsor ID
- STUDY00011960
- Conditions
- Covid 19, Vitamin D Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Southwest College of Naturopathic Medicine
- Study start
- 19 May 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 29 May 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.
This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D.
Detailed description
Protocol for Part 1:
- A single blood draw at SCNM to measure levels of vitamin D and other nutrients, comprehensive metabolic panel, and complete blood count with differential
- Completing a medical history/symptom form
- Completing a form about COVID-19 symptoms every 2 weeks for 6 weeks
- Authorization for release of medical records related to COVID 19 testing and/or treatment.
Protocol for Part 2:
- Take a vitamin D supplement daily for two weeks, at a dosage of 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
- After two weeks of taking vitamin D, return to SCNM for a blood draw to remeasure levels of vitamin D, comprehensive metabolic panel, and complete blood count with differential. If vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.
- Completing questionnaires about COVID 19 symptoms at 2, 4, and 6 weeks after treatment begins (5 minutes each time).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label treatment study for people with COVID 19 and low levels of vitamin D
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Vitamin D3This group will receive vitamin D. The dosage for the first two weeks will be 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+) After two weeks of taking vitamin D, if vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult age 18 or older
- Previous positive test result for COVID 19
- Able to communicate clearly in English Exclusion Criteria for Part 1 (testing): none
- Participation in Part 1
- Vitamin D level below 30 ng/ml
Key exclusion criteria (5 listed)
- Liver impairment
- Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant.
- Pregnancy
- No symptoms for 2 weeks after positive COVID 19 test
- Recovered from symptoms
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 D3Oral vitamin D3 capsules | Dietary supplement | Treatment Group |
Primary outcome
Vitamin D levels
Time frame: baseline and after two weeks of vitamin D supplementation
change in level of Vitamin D, 25-Hydroxy between the two time points
severity of COVID 19 symptoms
Time frame: baseline and at 2 weeks after vitamin D supplementation
We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation
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 30 Dec 2021.
- Individual participant dataSharing planned: Undecided. Contact us if you wish to discuss sharing of de-identified data
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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.
James B Adams, PhD principal investigator
Arizona State University
Sarah Trahan, NMD principal investigator
Southwest College of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 in people with Covid 19 and Vitamin D Deficiency, run by Arizona State University 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 6 inclusion and 5 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 30 Dec 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Vitamin D levels (time frame: baseline and after two weeks of vitamin D supplementation). The study lists 2 primary outcomes in all. 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 30 Dec 2021.