Vitamin D Supplementation in Patients With COVID-19

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Dietary Supplement: Vitamin D; Dietary Supplement: Placebo

• Registration Number: NCT04449718
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-29
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Vitamin D	Patients will receive 200,000 IU of vitamin D3 on admission + conventional care
Placebo	Placebo	Patients will receive an equivalent amount of a placebo solution on admission + conventional care

Primary Outcome Measures

Name	Time	Method
Length of hospitalization	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 Outcome Measures

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

Trial Locations

Locations (1)

Clinical Hospital of the School of Medicine, University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil