COVID 19Phase 2/3NCT04386850
Oral 25-hydroxyvitamin D3 and COVID-19
A Phase 2/3 study testing Oral 25-Hydroxyvitamin D3 in people with COVID 19, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this clinical trial is to investigate the therapeutic efficacy of rapidly correcting vitamin D deficiency in adults with the use of 25-hydroxyvitamin D3 [25(OH)D3] for reducing the risk of acquiring the SARS-CoV-2 (COVID-19) viral infection and mitigating morbidity and mortality associated with this… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID 19
- What is being tested?
- Oral 25-Hydroxyvitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteIran
- Study dates
- 14 Apr 2020to 15 Mar 2021
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years old and younger than 75 years old for all study groups.
- Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type) in infected patients.
- No medications or disorders that would affect vitamin D metabolism
- Women must be on birth control and not pregnant
- Ability and willingness to give informed consent and comply with protocol requirements
Who cannot join
- Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogues
- Pregnant or lactating women;
- Severe underlying diseases, such as advanced malignant tumors, endstage lung disease, etc.
- History of elevated serum calcium >10.6 mg/dl; that is corrected for albumin concentration or subjects with a history of hypercalciuria and kidney stones.
- Chronic hepatic dysfunction, chronic kidney disease or intestinal malabsorption syndromes including inflammatory bowel disease.
- Supplementation with over the counter formulations of vitamin D2 or vitamin D3
Show all 11Show fewer
- Use of tanning bed or artificial UV exposure within the last two weeks.
- Consuming medication affecting vitamin D metabolism or absorption (anticonvulsants, anti-tuberculosis medication glucocorticoids, HIV medications and cholestyramine).
- Subjects with a history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogues.
- Subjects with a history of conditions that can lead to high serum calcium levels such as sarcoidosis, tuberculosis and some lymphomas associated with activated macrophages which increase the production of 1,25(OH)2D.
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Arash Shirvani, MD, PhD contact
Iran1 site, 1 recruiting
- Recruiting
Tehran University of Medical Sciences
Tehran
Zhila Maghbooli, PhD, +98 21 6670 6142, zhilayas@gmail.com
About this study
Official title: Preventive and Therapeutic Effects of Oral 25-hydroxyvitamin D3 on Coronavirus (COVID-19) in Adults
The goal of this clinical trial is to investigate the therapeutic efficacy of rapidly correcting vitamin D deficiency in adults with the use of 25-hydroxyvitamin D3 [25(OH)D3] for reducing the risk of acquiring the SARS-CoV-2 (COVID-19) viral infection and mitigating morbidity and mortality associated with this infection. This evidence-based hypothesis is related to several observations. Macrophages, activated T and B lymphocytes have a vitamin D receptor and 1,25-dihydroxyvitamin D3 induces defensin protein synthesis, influences immunoglobulin production and modulates T-cell cytokine production and functions. 1,25-dihydroxyvitamin D3 also reduces the angiotensin-converting enzyme 2 (ACE2) that is believed to serve as the binding site and gateway for COVID-19 to become infectious. This is a multicenter randomized3 doubleblinded placebo-controlled study aimed at determining the benefits of 25(OH)D3 treatment for the prevention of COVID-19 infection and improving clinical outcomes in infected patients. The investigators plan to recruit 1500 subjects in 3 study groups that include hospital health providers, patients with a positive test for COVID-19 and their relatives with a negative test. Eligible subjects in each study group with a documented serum level of 25(OH)D < 20 ng/mL will be randomized. Recruited subjects will be given 25 mcg of 25(OH)D3 daily or an identically appearing placebo at the time of randomization for two months. Three hospitals will participate and the sample size is foreseen to be equally distributed between the three. Since the clinical trial is designed as minimal risk a formal committee for data monitoring is not foreseen. However, potential toxicity will be monitored every 4 weeks with a serum calcium, albumin and creatinine by the PI and the study coordinators. If the corrected serum calcium increases above 10.6 mg/dl and a repeat confirms that the calcium is above 10.6 mg/dL the subject will be dropped from the study and referred to his or her PCP. Early signs and symptoms of vitamin D toxicity associated with hypercalcemia are increased thirst, increase in frequency of urination, especially at night. The subjects will be followed up weekly by phone to ask about their sign and symptoms.
Read the detailed description
Improvement in the vitamin D status i.e. total serum 25-hydroxyvitamin D in children and adults has been associated with reduced risk of upper respiratory tract infections including influenza A infection. The rationale for giving 25(OH)D3 rather than vitamin D3 is to rapidly improve the vitamin D status of the subjects who are at high risk of acquiring COVID 19 or who are infected by this very aggressive viral infection. It takes approximately 6-8 weeks to achieve a steady state blood level of 25(OH)D when ingesting a daily dose of vitamin D3 whereas ingesting 25(OH)D3 results in a rapid rise in its blood level reaching steady state within 48 hours. Based on the available literature it is reasonable to consider the possibility that vitamin D deficiency could increase risk of acquiring COVID 19 infection and exacerbating its infectivity and the body's cytokine response to it. It therefore seems plausible that the rapid improvement in vitamin D status by providing 25(OH)D3 may contribute to reducing the severity of illness caused by COVID-19, particularly in settings where hypovitaminosis D is frequent especially in people of color. Arguably, there is little evidence to date that improving the vitamin D status will reduce the infectivity risk or mitigate the devastating health consequences of COVID-19 infection. The proposed study to rapidly improve vitamin D status in adults who are at high risk of acquiring COVID- 19 or who are at risk for its morbidity and mortality will test the veracity of this evidence based hypothesis. Results from this study, especially if positive, would have far reaching global health consequences. Vitamin D3, vitamin D2 and 25-hydroxyvitamin D3 are readily available worldwide and could be quickly instituted as a rapid cost-effective method to help combat this pandemic.
- Conditions
- COVID 19
- Being tested
- Oral 25-Hydroxyvitamin D3
- Keywords
- COVID 19, Vitamin D, 25-hydroxyvitamin D3, 1,25-dihydroxyvitamin D3, Viral infection, Cytokine storm, supplementation, Clinical Trial, Health Care provider, Prevention, Treatment
- Medical subject headings
- COVID-19, Virus Diseases, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral 25-Hydroxyvitamin D3Drug
Subjects in the case group will receive 25 mcg of 25(OH)D3 once daily at bedtime for 2 months and the control group will receive placebo daily for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Infected patients with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or with a COVID-19 positive test by the polymerase chain reaction (PCR) Receives: Drug: Oral 25-Hydroxyvitamin D3 |
| Prevention | Experimental | This arm of study includes the health care providers and hospital workers with a negative test for COVID-19 and a close patient relative with a negative test for COVID-19 who lives with the infected patients. Receives: Drug: Oral 25-Hydroxyvitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 (SARA-Cov-2) infection
Percentage of patients with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or patients with a COVID-19 positive test by the polymerase chain reaction (PCR)
Measured: 60 days
Severity of COVID-19 (SARA-Cov-2) infection
Percentage of mild, moderate and sever forms of COVID-19 based on WHO criteria
Measured: 60 days
Hospitalization
Percentage of patients who need to be hospitalized
Measured: 60 days
Disease duration
Days from the first symptom/positive test to discharge from hospital/negative test
Measured: 60 days
Death
Rate of death due to COVID-19 during the study
Measured: 60 days
Oxygen support
Percentage of COVID patients who need oxygen support
Measured: 60 days
Secondary outcomes (9)
Type of oxygen support
Percentage of COVID patients who require each: Nasal cannula, Non-invasive ventilation or high-flow nasal cannula, Invasive mechanical ventilation, Invasive mechanical ventilation and ECMO
Measured: 60 days
Symptoms of COVID-19
Percentage of COVID patients who display each: fever, dry cough, coughing sputum or blood, sore throat, headache, diarrhea and shortness of breath
Measured: 60 days
Serum Levels of 25-hydroxyvitamin D3
Serum Levels of 25-hydroxyvitamin D3 (ng/ml) by HPLC
Measured: 60 days
Serum levels of calcium
Serum calcium concentration (mg/dl)
Measured: 60 days
Serum levels of phosphorus
Serum phosphorus concentration (mg/dl)
Measured: 60 days
Serum levels of creatinine
Serum creatinine concentration (mg/dl)
Measured: 60 days
Serum levels of albumin
Serum albumin concentration (g/dl)
Measured: 60 days
Serum levels of the blood urea nitrogen (BUN)
Serum concentration of the blood urea nitrogen (mg/dl)
Measured: 60 days
Serum levels of the parathyroid hormone (PTH)
Serum concentration of the parathyroid hormone (pg/ml)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start14 Apr 2020
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter randomized double-blinded placebo-controlled clinical trial with parallel groups and allocation 1:1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Sponsor
- Investigators
- Mohamadali Sahraian, MD, Study chair, Tehran University of Medical Scienceszhila Maghbooli, PhD, Principal investigator, Tehran University of Medical SciencesMichael F Holick, PhD,MD, Principal investigator, Boston UniversityArash Shirvani, MD, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386850
- Sponsor's protocol ID
- IRCT2020-0401046909N2
- Other IDs
- IRCT20200401046909N1, IRCT2020-0401046909N2
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and analyzed during the current study will be available from the Study Principal Investigators (zhilayas@gmeil.com) on reasonable request .
Publications
Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.
PubMed 33757717
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive and Therapeutic Effects of Oral 25-hydroxyvitamin D3 on Coronavirus (COVID-19) in Adults
- ClinicalTrials.gov ID
- NCT04386850
- Acronym / sponsor ID
- IRCT2020-0401046909N2
- Conditions
- COVID 19
- Keywords
- COVID 19, Vitamin D, 25-hydroxyvitamin D3, 1,25-dihydroxyvitamin D3, Viral infection, Cytokine storm, supplementation, Clinical Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 13 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.
The goal of this clinical trial is to investigate the therapeutic efficacy of rapidly correcting vitamin D deficiency in adults with the use of 25-hydroxyvitamin D3 [25(OH)D3] for reducing the risk of acquiring the SARS-CoV-2 (COVID-19) viral infection and mitigating morbidity and mortality associated with this infection. This evidence-based hypothesis is related to several observations. Macrophages, activated T and B lymphocytes have a vitamin D receptor and 1,25-dihydroxyvitamin D3 induces defensin protein synthesis, influences immunoglobulin production and modulates T-cell cytokine production and functions. 1,25-dihydroxyvitamin D3 also reduces the angiotensin-converting enzyme 2 (ACE2) that is believed to serve as the binding site and gateway for COVID-19 to become infectious. This is a multicenter randomized3 doubleblinded placebo-controlled study aimed at determining the benefits of 25(OH)D3 treatment for the prevention of COVID-19 infection and improving clinical outcomes in infected patients. The investigators plan to recruit 1500 subjects in 3 study groups that include hospital health providers, patients with a positive test for COVID-19 and their relatives with a negative test. Eligible subjects in each study group with a documented serum level of 25(OH)D < 20 ng/mL will be randomized. Recruited subjects will be given 25 mcg of 25(OH)D3 daily or an identically appearing placebo at the time of randomization for two months. Three hospitals will participate and the sample size is foreseen to be equally distributed between the three. Since the clinical trial is designed as minimal risk a formal committee for data monitoring is not foreseen. However, potential toxicity will be monitored every 4 weeks with a serum calcium, albumin and creatinine by the PI and the study coordinators. If the corrected serum calcium increases above 10.6 mg/dl and a repeat confirms that the calcium is above 10.6 mg/dL the subject will be dropped from the study and referred to his or her PCP. Early signs and symptoms of vitamin D toxicity associated with hypercalcemia are increased thirst, increase in frequency of urination, especially at night. The subjects will be followed up weekly by phone to ask about their sign and symptoms.
Detailed description
Improvement in the vitamin D status i.e. total serum 25-hydroxyvitamin D in children and adults has been associated with reduced risk of upper respiratory tract infections including influenza A infection. The rationale for giving 25(OH)D3 rather than vitamin D3 is to rapidly improve the vitamin D status of the subjects who are at high risk of acquiring COVID 19 or who are infected by this very aggressive viral infection. It takes approximately 6-8 weeks to achieve a steady state blood level of 25(OH)D when ingesting a daily dose of vitamin D3 whereas ingesting 25(OH)D3 results in a rapid rise in its blood level reaching steady state within 48 hours. Based on the available literature it is reasonable to consider the possibility that vitamin D deficiency could increase risk of acquiring COVID 19 infection and exacerbating its infectivity and the body's cytokine response to it. It therefore seems plausible that the rapid improvement in vitamin D status by providing 25(OH)D3 may contribute to reducing the severity of illness caused by COVID-19, particularly in settings where hypovitaminosis D is frequent especially in people of color. Arguably, there is little evidence to date that improving the vitamin D status will reduce the infectivity risk or mitigate the devastating health consequences of COVID-19 infection. The proposed study to rapidly improve vitamin D status in adults who are at high risk of acquiring COVID- 19 or who are at risk for its morbidity and mortality will test the veracity of this evidence based hypothesis. Results from this study, especially if positive, would have far reaching global health consequences. Vitamin D3, vitamin D2 and 25-hydroxyvitamin D3 are readily available worldwide and could be quickly instituted as a rapid cost-effective method to help combat this pandemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter randomized double-blinded placebo-controlled clinical trial with parallel groups and allocation 1:1.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Oral 25-Hydroxyvitamin D3Infected patients with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or with a COVID-19 positive test by the polymerase chain reaction (PCR) |
| Prevention | Experimental | Drug: Oral 25-Hydroxyvitamin D3This arm of study includes the health care providers and hospital workers with a negative test for COVID-19 and a close patient relative with a negative test for COVID-19 who lives with the infected patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 18 years old and younger than 75 years old for all study groups.
- Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type) in infected patients.
- No medications or disorders that would affect vitamin D metabolism
- Women must be on birth control and not pregnant
- Ability and willingness to give informed consent and comply with protocol requirements
Key exclusion criteria (11 listed)
- Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogues
- Pregnant or lactating women;
- Severe underlying diseases, such as advanced malignant tumors, endstage lung disease, etc.
- History of elevated serum calcium >10.6 mg/dl; that is corrected for albumin concentration or subjects with a history of hypercalciuria and kidney stones.
- Chronic hepatic dysfunction, chronic kidney disease or intestinal malabsorption syndromes including inflammatory bowel disease.
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 |
|---|---|---|
| Oral 25-Hydroxyvitamin D3Subjects in the case group will receive 25 mcg of 25(OH)D3 once daily at bedtime for 2 months and the control group will receive placebo daily for 2 months. | Drug | Prevention, Treatment |
Primary outcome
COVID-19 (SARA-Cov-2) infection
Time frame: 60 days
Percentage of patients with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or patients with a COVID-19 positive test by the polymerase chain reaction (PCR)
Severity of COVID-19 (SARA-Cov-2) infection
Time frame: 60 days
Percentage of mild, moderate and sever forms of COVID-19 based on WHO criteria
Hospitalization
Time frame: 60 days
Percentage of patients who need to be hospitalized
Disease duration
Time frame: 60 days
Days from the first symptom/positive test to discharge from hospital/negative test
Death
Time frame: 60 days
Rate of death due to COVID-19 during the study
Oxygen support
Time frame: 60 days
Percentage of COVID patients who need oxygen support
9 secondary outcomes
Type of oxygen support
Time frame: 60 days
Symptoms of COVID-19
Time frame: 60 days
Serum Levels of 25-hydroxyvitamin D3
Time frame: 60 days
Serum levels of calcium
Time frame: 60 days
Serum levels of phosphorus
Time frame: 60 days
Serum levels of creatinine
Time frame: 60 days
Serum levels of albumin
Time frame: 60 days
Serum levels of the blood urea nitrogen (BUN)
Time frame: 60 days
Serum levels of the parathyroid hormone (PTH)
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 33757717Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.
- Individual participant dataSharing planned: Yes. The datasets used and analyzed during the current study will be available from the Study Principal Investigators (zhilayas@gmeil.com) on reasonable request .
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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.
Arash Shirvani, MD, PhD contact
Mohamadali Sahraian, MD study chair
Tehran University of Medical Sciences
zhila Maghbooli, PhD principal investigator
Tehran University of Medical Sciences
Michael F Holick, PhD,MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral 25-Hydroxyvitamin D3 in people with COVID 19, run by Tehran University of Medical Sciences at 1 site in Iran.
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 11 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: status not confirmed, as of the sponsor's last update on 12 Jun 2020. 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 Iran. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhila Maghbooli, PhD (+98 21 6670 6142, zhilayas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 (SARA-Cov-2) infection (time frame: 60 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386850, which also lists 1 linked publication.
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 12 Jun 2020.