Covid19Phase 4NCT04636086
Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection
A Phase 4 study testing Cholecalciferol in people with Covid19, run by University of Liege at 1 site in Belgium.
Trial summary
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2020to 15 May 2022
- Phase
- Phase 4
- 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
- Male and female over 18 years old (18 years inclusive).
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization.
- Expected to survive for at least 96 hours after study entry.
- If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence).
- Subject or legally authorized representative understands and agrees to comply with planned study procedures.
- Subject or legally authorized representative provides informed consent prior to initiation of any study procedures.
Who cannot join
- Women currently pregnant or breast-feeding.
- Patients presenting acute impairment of renal function or nephrolithiasis.
- Patients presenting hypercalcaemia and/or hypercalciuria
- Patients presenting pseudohypoparathyroidism
- Use of any vitamin D supplementation alone or in association at screening visit;
- Use of any prohibited medication as detailed in the concomitant medication section
- Patients with any sensitivity or allergy to any of the products used within this clinical trial.
- Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Supplementation and Covid-19: a Randomised, Double- Blind, Controlled Study
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Read the detailed description
Phase IV, interventional, randomised, double blind, placebo-controlled and parallel study to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Patients will participate in the study for a maximum of 9 weeks, which includes an up to 6-week treatment period and a maximum of 3-week follow-up period.
A total of 100 (50 in each group) patients will be randomized in the study and will either receive the test treatment or the placebo treatment.
- Conditions
- Covid19
- Being tested
- Cholecalciferol, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called D-Cure
Vitamin D supplementation
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Test treatment | Experimental | Test Treatment: Ampoule for enteral use containing 25,000 IU/mL of cholecalciferol taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36. Receives: Drug: Cholecalciferol |
| Placebo treatment | Placebo comparator | Placebo Treatment: Ampoule of placebo for enteral use containing excipient only taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D serum concentration
Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration
Measured: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Secondary outcomes (10)
Clinical improvement
Ordinal scale for clinical improvement as recommended by WHO
Measured: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Hospital length of stay.
Hospital length of stay.
Measured: at day 15 to 30 after hospital discharge
Intensive care unit length of stay.
Intensive care unit length of stay.
Measured: at day 15 to 30 after hospital discharge
Supplemental oxygen, non-invasive or invasive ventilation or organ support
Number of patients requiring supplemental oxygen, non-invasive ventilation or high flow oxygen devices, invasive mechanical ventilation or additional organ support (pressors, renal replacement therapy, extracorporeal membrane oxygenation).
Measured: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support
Duration of any organ support
Measured: at day 15 to 30 after hospital discharge
Absence of fever
Time until absence of fever for more than 48h without antipyretics.
Measured: Last day of hospitalization, or at at day 15 to 30 after hospital discharge
Time until negative laboratory SARS-CoV-2 test.
Time until negative laboratory SARS-CoV-2 test.
Measured: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Mortality all causes.
Mortality all causes.
Measured: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Mortality related to Covid-19.
Mortality related to Covid-19.
Measured: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Biological markers
Blood levels of C-reactive protein, interleukin 6 and 10, cathelicidin, white blood cells, creatinin and 1,25(OH)2-D3
Measured: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start12 Nov 2020
- Primary completion10 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires SMB S.A.
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636086
- Sponsor's protocol ID
- D-COVID
- Status last verified
- May 2022
- First submitted
- 17 Nov 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amrein K, Zajic P, Schnedl C, Waltensdorfer A, Fruhwald S, Holl A, Purkart T, Wunsch G, Valentin T, Grisold A, Stojakovic T, Amrein S, Pieber TR, Dobnig H. Vitamin D status and its association with season, hospital and sepsis mortality in critical illness. Crit Care. 2014 Mar 24;18(2):R47. doi: 10.1186/cc13790.
PubMed 24661739Amrein K, Litonjua AA, Moromizato T, Quraishi SA, Gibbons FK, Pieber TR, Camargo CA Jr, Giovannucci E, Christopher KB. Increases in pre-hospitalization serum 25(OH)D concentrations are associated with improved 30-day mortality after hospital admission: A cohort study. Clin Nutr. 2016 Apr;35(2):514-521. doi: 10.1016/j.clnu.2015.03.020. Epub 2015 Apr 14.
PubMed 25935851Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.
PubMed 25268295Barlow PG, Beaumont PE, Cosseau C, Mackellar A, Wilkinson TS, Hancock RE, Haslett C, Govan JR, Simpson AJ, Davidson DJ. The human cathelicidin LL-37 preferentially promotes apoptosis of infected airway epithelium. Am J Respir Cell Mol Biol. 2010 Dec;43(6):692-702. doi: 10.1165/rcmb.2009-0250OC. Epub 2010 Jan 22.
PubMed 20097832Barnett N, Zhao Z, Koyama T, Janz DR, Wang CY, May AK, Bernard GR, Ware LB. Vitamin D deficiency and risk of acute lung injury in severe sepsis and severe trauma: a case-control study. Ann Intensive Care. 2014 Feb 24;4(1):5. doi: 10.1186/2110-5820-4-5.
PubMed 24559079Beard JA, Bearden A, Striker R. Vitamin D and the anti-viral state. J Clin Virol. 2011 Mar;50(3):194-200. doi: 10.1016/j.jcv.2010.12.006. Epub 2011 Jan 15.
PubMed 21242105Braun AB, Gibbons FK, Litonjua AA, Giovannucci E, Christopher KB. Low serum 25-hydroxyvitamin D at critical care initiation is associated with increased mortality. Crit Care Med. 2012 Jan;40(1):63-72. doi: 10.1097/CCM.0b013e31822d74f3.
PubMed 21926604Cavalier E, Fache W, Souberbielle JC. A Randomised, Double-Blinded, Placebo-Controlled, Parallel Study of Vitamin D3 Supplementation with Different Schemes Based on Multiples of 25,000 IU Doses. Int J Endocrinol. 2013;2013:327265. doi: 10.1155/2013/327265. Epub 2013 Jan 28.
PubMed 23431293Abhimanyu, Coussens AK. The role of UV radiation and vitamin D in the seasonality and outcomes of infectious disease. Photochem Photobiol Sci. 2017 Mar 16;16(3):314-338. doi: 10.1039/c6pp00355a.
PubMed 28078341Dancer RC, Parekh D, Lax S, D'Souza V, Zheng S, Bassford CR, Park D, Bartis DG, Mahida R, Turner AM, Sapey E, Wei W, Naidu B, Stewart PM, Fraser WD, Christopher KB, Cooper MS, Gao F, Sansom DM, Martineau AR, Perkins GD, Thickett DR. Vitamin D deficiency contributes directly to the acute respiratory distress syndrome (ARDS). Thorax. 2015 Jul;70(7):617-24. doi: 10.1136/thoraxjnl-2014-206680. Epub 2015 Apr 22.
PubMed 25903964Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.
PubMed 32169119De Niet S, Coffiner M, Da Silva S, Jandrain B, Souberbielle JC, Cavalier E. A Randomized Study to Compare a Monthly to a Daily Administration of Vitamin D(3) Supplementation. Nutrients. 2018 May 23;10(6):659. doi: 10.3390/nu10060659.
PubMed 29882841Gombart AF, Pierre A, Maggini S. A Review of Micronutrients and the Immune System-Working in Harmony to Reduce the Risk of Infection. Nutrients. 2020 Jan 16;12(1):236. doi: 10.3390/nu12010236.
PubMed 31963293Grant WB, Lahore H, McDonnell SL, Baggerly CA, French CB, Aliano JL, Bhattoa HP. Evidence that Vitamin D Supplementation Could Reduce Risk of Influenza and COVID-19 Infections and Deaths. Nutrients. 2020 Apr 2;12(4):988. doi: 10.3390/nu12040988.
PubMed 32252338Greiller CL, Martineau AR. Modulation of the immune response to respiratory viruses by vitamin D. Nutrients. 2015 May 29;7(6):4240-70. doi: 10.3390/nu7064240.
PubMed 26035247
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation and Covid-19: a Randomised, Double- Blind, Controlled Study
- ClinicalTrials.gov ID
- NCT04636086
- Acronym / sponsor ID
- D-COVID
- Conditions
- Covid19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Laboratoires SMB S.A.
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 19 Nov 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 objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Detailed description
Phase IV, interventional, randomised, double blind, placebo-controlled and parallel study to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Patients will participate in the study for a maximum of 9 weeks, which includes an up to 6-week treatment period and a maximum of 3-week follow-up period.
A total of 100 (50 in each group) patients will be randomized in the study and will either receive the test treatment or the placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test treatment | Experimental | Drug: CholecalciferolTest Treatment: Ampoule for enteral use containing 25,000 IU/mL of cholecalciferol taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36. |
| Placebo treatment | Placebo comparator | Other: PlaceboPlacebo Treatment: Ampoule of placebo for enteral use containing excipient only taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female over 18 years old (18 years inclusive).
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization.
- Expected to survive for at least 96 hours after study entry.
- If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence).
- Subject or legally authorized representative understands and agrees to comply with planned study procedures.
Key exclusion criteria (8 listed)
- Women currently pregnant or breast-feeding.
- Patients presenting acute impairment of renal function or nephrolithiasis.
- Patients presenting hypercalcaemia and/or hypercalciuria
- Patients presenting pseudohypoparathyroidism
- Use of any vitamin D supplementation alone or in association at screening visit;
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 |
|---|---|---|
| CholecalciferolAlso: D-CureVitamin D supplementation | Drug | Test treatment |
| PlaceboPlacebo comparator | Other | Placebo treatment |
Primary outcome
Vitamin D serum concentration
Time frame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration
10 secondary outcomes
Clinical improvement
Time frame: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Hospital length of stay.
Time frame: at day 15 to 30 after hospital discharge
Intensive care unit length of stay.
Time frame: at day 15 to 30 after hospital discharge
Supplemental oxygen, non-invasive or invasive ventilation or organ support
Time frame: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support
Time frame: at day 15 to 30 after hospital discharge
Absence of fever
Time frame: Last day of hospitalization, or at at day 15 to 30 after hospital discharge
Time until negative laboratory SARS-CoV-2 test.
Time frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Mortality all causes.
Time frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Mortality related to Covid-19.
Time frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Biological markers
Time frame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
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 19 May 2022.
- Background: PubMed 24661739Amrein K, Zajic P, Schnedl C, Waltensdorfer A, Fruhwald S, Holl A, Purkart T, Wunsch G, Valentin T, Grisold A, Stojakovic T, Amrein S, Pieber TR, Dobnig H. Vitamin D status and its association with season, hospital and sepsis mortality in critical illness. Crit Care. 2014 Mar 24;18(2):R47. doi: 10.1186/cc13790.
- Background: PubMed 25935851Amrein K, Litonjua AA, Moromizato T, Quraishi SA, Gibbons FK, Pieber TR, Camargo CA Jr, Giovannucci E, Christopher KB. Increases in pre-hospitalization serum 25(OH)D concentrations are associated with improved 30-day mortality after hospital admission: A cohort study. Clin Nutr. 2016 Apr;35(2):514-521. doi: 10.1016/j.clnu.2015.03.020. Epub 2015 Apr 14.
- Background: PubMed 25268295Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.
- Background: PubMed 20097832Barlow PG, Beaumont PE, Cosseau C, Mackellar A, Wilkinson TS, Hancock RE, Haslett C, Govan JR, Simpson AJ, Davidson DJ. The human cathelicidin LL-37 preferentially promotes apoptosis of infected airway epithelium. Am J Respir Cell Mol Biol. 2010 Dec;43(6):692-702. doi: 10.1165/rcmb.2009-0250OC. Epub 2010 Jan 22.
- Background: PubMed 24559079Barnett N, Zhao Z, Koyama T, Janz DR, Wang CY, May AK, Bernard GR, Ware LB. Vitamin D deficiency and risk of acute lung injury in severe sepsis and severe trauma: a case-control study. Ann Intensive Care. 2014 Feb 24;4(1):5. doi: 10.1186/2110-5820-4-5.
- Background: PubMed 21242105Beard JA, Bearden A, Striker R. Vitamin D and the anti-viral state. J Clin Virol. 2011 Mar;50(3):194-200. doi: 10.1016/j.jcv.2010.12.006. Epub 2011 Jan 15.
- Background: PubMed 21926604Braun AB, Gibbons FK, Litonjua AA, Giovannucci E, Christopher KB. Low serum 25-hydroxyvitamin D at critical care initiation is associated with increased mortality. Crit Care Med. 2012 Jan;40(1):63-72. doi: 10.1097/CCM.0b013e31822d74f3.
- Background: PubMed 23431293Cavalier E, Fache W, Souberbielle JC. A Randomised, Double-Blinded, Placebo-Controlled, Parallel Study of Vitamin D3 Supplementation with Different Schemes Based on Multiples of 25,000 IU Doses. Int J Endocrinol. 2013;2013:327265. doi: 10.1155/2013/327265. Epub 2013 Jan 28.
- Background: PubMed 28078341Abhimanyu, Coussens AK. The role of UV radiation and vitamin D in the seasonality and outcomes of infectious disease. Photochem Photobiol Sci. 2017 Mar 16;16(3):314-338. doi: 10.1039/c6pp00355a.
- Background: PubMed 25903964Dancer RC, Parekh D, Lax S, D'Souza V, Zheng S, Bassford CR, Park D, Bartis DG, Mahida R, Turner AM, Sapey E, Wei W, Naidu B, Stewart PM, Fraser WD, Christopher KB, Cooper MS, Gao F, Sansom DM, Martineau AR, Perkins GD, Thickett DR. Vitamin D deficiency contributes directly to the acute respiratory distress syndrome (ARDS). Thorax. 2015 Jul;70(7):617-24. doi: 10.1136/thoraxjnl-2014-206680. Epub 2015 Apr 22.
- Background: PubMed 32169119Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.
- Background: PubMed 29882841De Niet S, Coffiner M, Da Silva S, Jandrain B, Souberbielle JC, Cavalier E. A Randomized Study to Compare a Monthly to a Daily Administration of Vitamin D(3) Supplementation. Nutrients. 2018 May 23;10(6):659. doi: 10.3390/nu10060659.
- Individual participant dataSharing planned: No
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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 4 study testing Cholecalciferol in people with Covid19, run by University of Liege at 1 site in Belgium.
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 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 19 May 2022. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 serum concentration (time frame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge). 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 NCT04636086, which also lists 20 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 19 May 2022.