SARPhase 3NCT04621058
Efficacy of Vitamin D Treatment in Mortality Reduction Due to COVID-19.
A Phase 3 study testing Vitamin D in people with SAR and SARS Pneumonia, run by Bioaraba Health Research Institute at 1 site in Spain.
Trial summary
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SAR, SARS Pneumonia
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 9 Nov 2020to 30 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted to the Respiratory or Internal medicine Units of Santiago hospital (HUA) due to pneumonia.
- Vitamin D deficiency (25(OH) defined by blood levels below 30 mg/ml.
- Possibility for observation during the treatment period.
- Signing of written consent (oral informed consent exceptionally).
- Positive PCR for diagnosis of sars-cov2 infection
Who cannot join
- Patients taking any type of vitamin D supplement.
- Patients with hypoparathyroidism.
- Pregnant or lactating women.
- Patients in whom the administration of vitamin D is formally contraindicated (see annex VI).
- Patients who at time of inclusion, cannot take vitamin D orally.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Treatment With Vitamin D in Patients Diagnosed With COVID-19 Who Presenting Vitamin D Deficiency and Pneumonia.
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
Read more
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
Read the detailed description
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
Inclusion criteria: Adult patients admitted to the Respiratory/Internal Medicine Unit of Santiago hospital of the OSI Araba HUA for acute pneumonia and suffering from a vitamin D deficit (< 30 ng/ml) and a RT-PCR, in nasopharyngeal exudate, positive for SARS-CoV-2.
Exclusion criteria: 1)Patients taking any type of vitamin D supplement. 2)Patients with hypoparathyroidism. 3) Patients in whom the administration of vitamin D is formally contraindicated. 4) Patients who cannot take vitamin D orally.
OUR SIZE: In order to answer to the main objective (mortality reduction 21% versus 50% intervention and control group respectively), we will need a total sample of 108 evaluable subjects-54 patients per group (J Crit Care. 2018;44:300-5).Statistical power 90%,95% statistical significance with possible loss of follow-up of 5% of patients.
A recruitment period of about 12 months is needed.
STATISTICAL ANALYSIS: In order to answer to the main and secondary objectives (mortality and ICU admission), the Chi-square test will be performed and in the event that any of the frequencies is less than 5, the exact Fisher test will be used.
Depending on the distribution of the quantitative variables, the Student t-test for independent samples or the non-parametric Mann-Whitney U-test will be used, respectively.
The analysis criterion will be "by intention to treat". In all cases. The statistical significance will be 95%.
- Conditions
- SAR, SARS Pneumonia
- Being tested
- Vitamin D, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called D VITAMIN GROUP
In case of Vitamin D levels <30 or 40ng/ml patients will take vitamin D supplements.
PLACEBODrug
Also called PLACEO GROUP
Placebo capsules exactly the same as the above, but without the active component.
| Study group | Role | What they receive |
|---|---|---|
| D VITAMIN GROUP | Experimental | The administration of vitamin D will be carried out using the following treatment scheme:
If vitamin D deficiency (< 30 ng/ml) treatment with 2 capsules of 0.266 mg If vitamin D deficiency (< 40 ng/ml): treatment with 1 capsule of 0.266 mg
Blood levels of vitamin D will be determined on day 1, 4, 7 and 14. Based on the results from day 14, a new determination is recommended 4 weeks after starting treatment with the primary care physician who will decide whether to continue or interrupt the treatment. This phase will be carried out outside of the study.
In addition, the product should only be administered, if blood calcium and phosphorus levels are within normal limits, as well as if the creatinuria/calciuria ratio is within normal ranges. Receives: Drug: Vitamin D |
| PLACEBO GROUP | Placebo comparator | The procedure will be the same as in the experimental group but instead of the active component, patients will take placebo capsules exactly the same as above but without the active component. Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
MORTALITY
Mortality reduction
Measured: At 21 days.
Secondary outcomes (4)
Intensive care admissions
Intensive care admissions reduction
Measured: At 21 days
Length of hospital stay
Length of hospital stay reduction
Measured: AT 21 DAYS
Prevalence of vitamin D deficiency
To assess the prevalence of vitamin D deficiency at baseline
Measured: At baseline
Incremental cost effectiveness ratio (ICER)
To calculate the incremental cost per event (mortality) avoided
Measured: At 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start9 Nov 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaraba Health Research Institute
- Sponsor type
- Research network
- Collaborators
- Fundación Eduardo Anitua
- Responsible party
- Sponsor
- Investigators
- Joaquín Durán Cantolla, Principal investigator, Bioaraba Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621058
- Sponsor's protocol ID
- VITD
- Status last verified
- Jul 2022
- First submitted
- 6 Nov 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment With Vitamin D in Patients Diagnosed With COVID-19 Who Presenting Vitamin D Deficiency and Pneumonia.
- ClinicalTrials.gov ID
- NCT04621058
- Acronym / sponsor ID
- VITD
- Conditions
- SAR, SARS Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Bioaraba Health Research InstituteResearch network
- Collaborators
- Fundación Eduardo Anitua
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 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.
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
Detailed description
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
Inclusion criteria: Adult patients admitted to the Respiratory/Internal Medicine Unit of Santiago hospital of the OSI Araba HUA for acute pneumonia and suffering from a vitamin D deficit (< 30 ng/ml) and a RT-PCR, in nasopharyngeal exudate, positive for SARS-CoV-2.
Exclusion criteria: 1)Patients taking any type of vitamin D supplement. 2)Patients with hypoparathyroidism. 3) Patients in whom the administration of vitamin D is formally contraindicated. 4) Patients who cannot take vitamin D orally.
OUR SIZE: In order to answer to the main objective (mortality reduction 21% versus 50% intervention and control group respectively), we will need a total sample of 108 evaluable subjects-54 patients per group (J Crit Care. 2018;44:300-5).Statistical power 90%,95% statistical significance with possible loss of follow-up of 5% of patients.
A recruitment period of about 12 months is needed.
STATISTICAL ANALYSIS: In order to answer to the main and secondary objectives (mortality and ICU admission), the Chi-square test will be performed and in the event that any of the frequencies is less than 5, the exact Fisher test will be used.
Depending on the distribution of the quantitative variables, the Student t-test for independent samples or the non-parametric Mann-Whitney U-test will be used, respectively.
The analysis criterion will be "by intention to treat". In all cases. The statistical significance will be 95%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| D VITAMIN GROUP | Experimental | Drug: Vitamin DThe administration of vitamin D will be carried out using the following treatment scheme: If vitamin D deficiency (< 30 ng/ml) treatment with 2 capsules of 0.266 mg If vitamin D deficiency (< 40 ng/ml): treatment with 1 capsule of 0.266 mg Blood levels of vitamin D will be determined on day 1, 4, 7 and 14. Based on the results from day 14, a new determination is recommended 4 weeks after starting treatment with the primary care physician who will decide whether to continue or interrupt the treatment. This phase will be carried out outside of the study. In addition, the product should only be administered, if blood calcium and phosphorus levels are within normal limits, as well as if the creatinuria/calciuria ratio is within normal ranges. |
| PLACEBO GROUP | Placebo comparator | Drug: PLACEBOThe procedure will be the same as in the experimental group but instead of the active component, patients will take placebo capsules exactly the same as above but without the active component. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to the Respiratory or Internal medicine Units of Santiago hospital (HUA) due to pneumonia.
- Vitamin D deficiency (25(OH) defined by blood levels below 30 mg/ml.
- Possibility for observation during the treatment period.
- Signing of written consent (oral informed consent exceptionally).
- Positive PCR for diagnosis of sars-cov2 infection
Key exclusion criteria (5 listed)
- Patients taking any type of vitamin D supplement.
- Patients with hypoparathyroidism.
- Pregnant or lactating women.
- Patients in whom the administration of vitamin D is formally contraindicated (see annex VI).
- Patients who at time of inclusion, cannot take vitamin D orally.
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 DAlso: D VITAMIN GROUPIn case of Vitamin D levels <30 or 40ng/ml patients will take vitamin D supplements. | Drug | D VITAMIN GROUP |
| PLACEBOAlso: PLACEO GROUPPlacebo capsules exactly the same as the above, but without the active component. | Drug | PLACEBO GROUP |
Primary outcome
MORTALITY
Time frame: At 21 days.
Mortality reduction
4 secondary outcomes
Intensive care admissions
Time frame: At 21 days
Length of hospital stay
Time frame: AT 21 DAYS
Prevalence of vitamin D deficiency
Time frame: At baseline
Incremental cost effectiveness ratio (ICER)
Time frame: At 21 days
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 15 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for SAR
Recruiting
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
CAD
RecruitingObservational study
LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy and Spectroscopy-based Molecular Urinalysis in Sarcoma Patients
Sarcoma
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
RecruitingPhase 3
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Prostate Cancer, Prostatic Neoplasms
RecruitingPhase 3
Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR)
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.
Joaquín Durán Cantolla principal investigator
Bioaraba Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with SAR and SARS Pneumonia, run by Bioaraba Health Research Institute at 1 site in Spain.
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 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 15 Jul 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 Spain. 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 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?
MORTALITY (time frame: At 21 days.). 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 15 Jul 2022.