CoronavirusPhase 3NCT04344041
COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)
A Phase 3 study testing cholecalciferol 200,000 IU and cholecalciferol 50,000 IU in people with Coronavirus, run by University Hospital, Angers at 9 sites in France.
Trial summary
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- cholecalciferol 200,000 IU and cholecalciferol 50,000 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 9 sitesFrance
- Study dates
- 15 Apr 2020to 14 Jan 2021
- Phase
- Phase 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years old
- Infection with COVID-19 diagnosed with RT-PCR SARS-CoV-2 or withCT-scan of the chest suggesting viral pneumonia of peripheral predominance in a clinically relevant context
- Patient seen in hospitalization or consultation or in nursing home
- Diagnosed within the preceding 3 days
- Having at least one of the following two risk factors for complications:
- age ≥75 years
Show all 9Show fewer
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg
- Patients affiliated with or benefitting from a social security scheme
- Written and signed consent of the patient or a relative or legal representative or, if not possible, emergency inclusion procedure
Who cannot join
- Organ failure requiring admission to a resuscitation or high dependency unit
- Comorbidity that is life-threatening in the short-term (life expectancy <3 months)
- Any reason that makes follow-up at day 28 impossible
- Vitamin D supplementation in the previous month, with the exception of treatment providing less than 800 IU of vitamin D per day
- Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D
- Participation in another simultaneous trial
- Safeguard of justice
- Peripheral capillary oxygen saturation (SpO2) ≤92% in spite of an oxygen therapy > 5L/min
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU Angers
Angers
CHU Bordeaux
Bordeaux
CH Le Mans
Le Mans
CHU Limoges
Limoges
CHU Nantes
Nantes
CHU Nice
Nice
CHU Saint Etienne
Saint-Etienne
CH Saumur
Saumur
CHU Tours
Tours
About this study
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator.
In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths.
Read more
Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS).
Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections.
High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status.
Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now.
We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.
Read the detailed description
- Inclusion visit A clinical examination is carried out. Social-demographic measures, health history, clinical examination measures (including OSCI score) and biological measures are collected.
Randomization is conducted on the day of the inclusion visit. The ZYMAD® 400,000 IU (2 vials of 200,000 IU) or 50,000 IU (1 vial of 50,000 IU) treatment is given to the patient.
- Visit at day 7 A blood test is carried out by a nurse to determine the serum 25-OHD, creatrinine, albumine and calcium concentrations.
- Visit at day 14 A visit or telephone call allows recording the onset of clinical events of interest. The drugs received as part of the usual treatment during the last 14 days are collected.
- Visit at day 28 A visit or telephone call allows recording the onset of clinical events of interest. The drugs received as part of the usual treatment during the last 14 days are collected.
- Conditions
- Coronavirus
- Being tested
- cholecalciferol 200,000 IU, cholecalciferol 50,000 IU
- Keywords
- vitamin D, older adults
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol 200,000 IUDrug
Patients receive a vitamin D supplementation of 400,000 IU in a single oral dose.
cholecalciferol 50,000 IUDrug
Patients receive a vitamin D supplementation of 50,000 IU in a single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | High dose of vitamin D3 Receives: Drug: cholecalciferol 200,000 IU |
| Comparator group | Active comparator | Standard dose of vitamin D3 Receives: Drug: cholecalciferol 50,000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death of any cause, during the 14 days following the inclusion and intervention.
Measured: Day 14
Secondary outcomes (21)
Number of death of any cause, during the 28 days following the inclusion and intervention.
Measured: Day 28
Clinical evolution between day 0 and day 14 based on the change of the WHO Ordinal Scale for Clinical Improvement (OSCI) for COVID-19
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 28
Rate of patients with at least one severe adverse event at day 28, according to the regulations
Measured: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
Measured: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
Measured: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at baseline
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Measured: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Measured: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Measured: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Measured: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7
Measured: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7
Measured: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7
OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measured: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, compared to mortality data in French hospital geriatric units from the current national survey by the French Society of Geriatrics and Gerontology
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Apr 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Mylan Laboratories
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344041
- Sponsor's protocol ID
- 2020-001602-34
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Annweiler C, Beaudenon M, Gautier J, Gonsard J, Boucher S, Chapelet G, Darsonval A, Fougere B, Guerin O, Houvet M, Menager P, Roubaud-Baudron C, Tchalla A, Souberbielle JC, Riou J, Parot-Schinkel E, Celarier T; COVIT-TRIAL study group. High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial. PLoS Med. 2022 May 31;19(5):e1003999. doi: 10.1371/journal.pmed.1003999. eCollection 2022 May.
PubMed 35639792Shakoor 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 33757717Annweiler C, Beaudenon M, Gautier J, Simon R, Dubee V, Gonsard J, Parot-Schinkel E; COVIT-TRIAL study group. COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial. Trials. 2020 Dec 28;21(1):1031. doi: 10.1186/s13063-020-04928-5.
PubMed 33371905
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)
- ClinicalTrials.gov ID
- NCT04344041
- Acronym / sponsor ID
- 2020-001602-34
- Conditions
- Coronavirus
- Keywords
- vitamin D, older adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Mylan Laboratories
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 14 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.
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator.
In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths.
Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS).
Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections.
High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status.
Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now.
We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.
Detailed description
- Inclusion visit A clinical examination is carried out. Social-demographic measures, health history, clinical examination measures (including OSCI score) and biological measures are collected.
Randomization is conducted on the day of the inclusion visit. The ZYMAD® 400,000 IU (2 vials of 200,000 IU) or 50,000 IU (1 vial of 50,000 IU) treatment is given to the patient.
- Visit at day 7 A blood test is carried out by a nurse to determine the serum 25-OHD, creatrinine, albumine and calcium concentrations.
- Visit at day 14 A visit or telephone call allows recording the onset of clinical events of interest. The drugs received as part of the usual treatment during the last 14 days are collected.
- Visit at day 28 A visit or telephone call allows recording the onset of clinical events of interest. The drugs received as part of the usual treatment during the last 14 days are collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: cholecalciferol 200,000 IUHigh dose of vitamin D3 |
| Comparator group | Active comparator | Drug: cholecalciferol 50,000 IUStandard dose of vitamin D3 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Age ≥ 65 years old
- Infection with COVID-19 diagnosed with RT-PCR SARS-CoV-2 or withCT-scan of the chest suggesting viral pneumonia of peripheral predominance in a clinically relevant context
- Patient seen in hospitalization or consultation or in nursing home
- Diagnosed within the preceding 3 days
- Having at least one of the following two risk factors for complications:
Key exclusion criteria (8 listed)
- Organ failure requiring admission to a resuscitation or high dependency unit
- Comorbidity that is life-threatening in the short-term (life expectancy <3 months)
- Any reason that makes follow-up at day 28 impossible
- Vitamin D supplementation in the previous month, with the exception of treatment providing less than 800 IU of vitamin D per day
- Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D
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 |
|---|---|---|
| cholecalciferol 200,000 IUPatients receive a vitamin D supplementation of 400,000 IU in a single oral dose. | Drug | Intervention group |
| cholecalciferol 50,000 IUPatients receive a vitamin D supplementation of 50,000 IU in a single oral dose | Drug | Comparator group |
Primary outcome
Number of death of any cause, during the 14 days following the inclusion and intervention.
Time frame: Day 14
21 secondary outcomes
Number of death of any cause, during the 28 days following the inclusion and intervention.
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the WHO Ordinal Scale for Clinical Improvement (OSCI) for COVID-19
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19
Time frame: Day 28
Rate of patients with at least one severe adverse event at day 28, according to the regulations
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at baseline
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L)
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L)
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7
Time frame: Day 14
Number of death of any cause during the 28 days following the inclusion and intervention, depending on evolution of serum vitamin D concentration between day 0 and day 7
Time frame: Day 28
Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7
Time frame: Day 14
Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7
Time frame: Day 28
Number of death of any cause during the 14 days following the inclusion and intervention, compared to mortality data in French hospital geriatric units from the current national survey by the French Society of Geriatrics and Gerontology
Time frame: Day 14
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 Apr 2021.
- Derived from this study: PubMed 35639792Annweiler C, Beaudenon M, Gautier J, Gonsard J, Boucher S, Chapelet G, Darsonval A, Fougere B, Guerin O, Houvet M, Menager P, Roubaud-Baudron C, Tchalla A, Souberbielle JC, Riou J, Parot-Schinkel E, Celarier T; COVIT-TRIAL study group. High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial. PLoS Med. 2022 May 31;19(5):e1003999. doi: 10.1371/journal.pmed.1003999. eCollection 2022 May.
- 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.
- Derived from this study: PubMed 33371905Annweiler C, Beaudenon M, Gautier J, Simon R, Dubee V, Gonsard J, Parot-Schinkel E; COVIT-TRIAL study group. COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial. Trials. 2020 Dec 28;21(1):1031. doi: 10.1186/s13063-020-04928-5.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cholecalciferol 200,000 IU and cholecalciferol 50,000 IU in people with Coronavirus, run by University Hospital, Angers at 9 sites in France.
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 9 inclusion and 8 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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 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?
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?
Number of death of any cause, during the 14 days following the inclusion and intervention. (time frame: Day 14). 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 NCT04344041, which also lists 3 linked publications.
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 Apr 2021.