Vitamin D Supplementation in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449718
• Other study ID #: 30959620.4.0000.0068
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 7, 2020

Study information

• Verified date: June 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Dietary Supplement:
• Vitamin D
200,000 IU on admission
• Placebo
200,000 IU on admission

Locations

Country	Name	City	State
Brazil	Clinical Hospital of the School of Medicine, University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization	total number of days that patient remained hospitalized	From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Secondary	Mortality	number of patients that died	From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Secondary	Number of cases admitted to Intensive Care Unit (ICU)	total number of days that patient remained in ICU	From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Secondary	Length of use of mechanic ventilator	total number of days that patient remained in mechanic ventilator	From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Secondary	Number and severity of symptoms		From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Secondary	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	Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Secondary	C-reactive protein	serum concentration	Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Secondary	Vitamin D	serum concentration	Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Secondary	Creatinine	serum concentration	Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Secondary	Calcium	serum concentration	Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Secondary	Physical activity	Baecke questionnaire (higher scores mean a higher physical activity level)	Baseline