AzTrials
AzTrials

COVID-19NCT04449718

Vitamin D Supplementation in Patients With COVID-19

A study testing Vitamin D in people with COVID-19, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Vitamin D
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteBrazil
Study dates
1 Jun 2020to 7 Oct 2020
Phase
Interventional
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

  • Diagnosis of flu syndrome with hospitalization criteria;
  • Respiratory rate ≥ 24irpm and / or saturation <93% in room air, or belonging to the risk group for complications: 1. Chronic diseases: heart disease, diabetes mellitus, systemic arterial hypertension and neoplasms, 2. Immunosuppression, 3. Pulmonary tuberculosis; 4. Obesity;
  • Tomographic findings compatible with coronavirus disease.

Who cannot join

  • Patient admitted already under invasive mechanical ventilation;
  • Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
  • Prior vitamin D supplementation (above 1000 IU/day);
  • Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
  • Admitted patients with expected hospital discharge in less than 24 hours;
  • Patient unable to sign the consent form.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Clinical Hospital of the School of Medicine, University of Sao Paulo

    São Paulo, 05403-000

Other trials in Brazil

About this study

Official title: Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial

Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.

Conditions
COVID-19
Being tested
Vitamin D, Placebo
Keywords
COVID-19, vitamin D, acute respiratory syndrome
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDietary supplement

    200,000 IU on admission

  • PlaceboDietary supplement

    200,000 IU on admission

Study groups in NCT04449718
Study groupRoleWhat they receive
ExperimentalExperimentalPatients will receive 200,000 IU of vitamin D3 on admission + conventional care
Receives: Dietary Supplement: Vitamin D
PlaceboPlacebo comparatorPatients will receive an equivalent amount of a placebo solution on admission + conventional care
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of hospitalization

    total number of days that patient remained hospitalized

    Measured: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month

Secondary outcomes (10)

  1. Mortality

    number of patients that died

    Measured: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month

  2. Number of cases admitted to Intensive Care Unit (ICU)

    total number of days that patient remained in ICU

    Measured: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month

  3. Length of use of mechanic ventilator

    total number of days that patient remained in mechanic ventilator

    Measured: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month

  4. Number and severity of symptoms

    Measured: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month

  5. Inflammatory markers

    C-reactive protein, IL-1alpha (pg/ml), IL-1beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml), IL-1ra (pg/ml), IL-10 (pg/ml) concentration in the serum

    Measured: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)

  6. C-reactive protein

    serum concentration

    Measured: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)

  7. Vitamin D

    serum concentration

    Measured: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)

  8. Creatinine

    serum concentration

    Measured: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)

  9. Calcium

    serum concentration

    Measured: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)

  10. Physical activity

    Baecke questionnaire (higher scores mean a higher physical activity level)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completion7 Oct 2020
  4. Study completion7 Oct 2020

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04449718
Sponsor's protocol ID
30959620.4.0000.0068
Status last verified
Jun 2020
First submitted
16 Jun 2020
Last updated
17 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sales LP, Souza LVB, Fernandes AL, Murai IH, Santos MD, Vendramini MBG, Oliveira RM, Figueiredo CP, Caparbo VF, Gualano B, Pereira RMR; in memoriam. Effect of vitamin D3 on antiphospholipid antibodies in hospitalized patients with moderate to severe COVID-19. Clinics (Sao Paulo). 2024 Aug 27;79:100474. doi: 10.1016/j.clinsp.2024.100474. eCollection 2024.

    PubMed 39208655

  • Fernandes LP, Murai IH, Fernandes AL, Sales LP, Rogero MM, Gualano B, Barroso LP, Milne GL, Pereira RMR, Castro IA. The severity of COVID-19 upon hospital admission is associated with plasma omega-3 fatty acids. Sci Rep. 2024 May 3;14(1):10238. doi: 10.1038/s41598-024-60815-y.

    PubMed 38702342

  • Fernandes AL, Sales LP, Santos MD, Caparbo VF, Murai IH, Pereira RMR. Persistent or new symptoms 1 year after a single high dose of vitamin D3 in patients with moderate to severe COVID-19. Front Nutr. 2022 Sep 13;9:979667. doi: 10.3389/fnut.2022.979667. eCollection 2022.

    PubMed 36176639

  • Fernandes AL, Murai IH, Reis BZ, Sales LP, Santos MD, Pinto AJ, Goessler KF, Duran CSC, Silva CBR, Franco AS, Macedo MB, Dalmolin HHH, Baggio J, Balbi GGM, Antonangelo L, Caparbo VF, Gualano B, Pereira RMR. Effect of a single high dose of vitamin D3 on cytokines, chemokines, and growth factor in patients with moderate to severe COVID-19. Am J Clin Nutr. 2022 Mar 4;115(3):790-798. doi: 10.1093/ajcn/nqab426.

    PubMed 35020796

  • Murai IH, Fernandes AL, Antonangelo L, Gualano B, Pereira RMR. Effect of a Single High-Dose Vitamin D3 on the Length of Hospital Stay of Severely 25-Hydroxyvitamin D-Deficient Patients with COVID-19. Clinics (Sao Paulo). 2021 Nov 26;76:e3549. doi: 10.6061/clinics/2021/e3549. eCollection 2021.

    PubMed 34852148

  • Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043.

    PubMed 34029377

  • Murai IH, Fernandes AL, Sales LP, Pinto AJ, Goessler KF, Duran CSC, Silva CBR, Franco AS, Macedo MB, Dalmolin HHH, Baggio J, Balbi GGM, Reis BZ, Antonangelo L, Caparbo VF, Gualano B, Pereira RMR. Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Mar 16;325(11):1053-1060. doi: 10.1001/jama.2020.26848.

    PubMed 33595634

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D in people with COVID-19, run by University of Sao Paulo at 1 site in Brazil.

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 3 inclusion and 6 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 17 Nov 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 Brazil. 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.

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?

Length of hospitalization (time frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month). 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 NCT04449718, which also lists 7 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 17 Nov 2020.

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