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Completed

NCT Number: NCT04449718

Vitamin D Supplementation in Patients With COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vitamin D

Dietary Supplement

200,000 IU on admission

Placebo

Dietary Supplement

200,000 IU on admission

Primary outcomes

  1. Length of hospitalization

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

    total number of days that patient remained hospitalized

Secondary outcomes

  1. Mortality

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

    number of patients that died

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

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

    total number of days that patient remained in ICU

  3. Length of use of mechanic ventilator

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

    total number of days that patient remained in mechanic ventilator

  4. Number and severity of symptoms

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

  5. Inflammatory markers

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

    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

  6. C-reactive protein

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

    serum concentration

  7. Vitamin D

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

    serum concentration

  8. Creatinine

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

    serum concentration

  9. Calcium

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

    serum concentration

  10. Physical activity

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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