Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04738760

Collaborator

Misr International University (Other)

116

Enrollment

Location

Actual Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Vitamin D is a secosteroid hormone which may have beneficial role in reducing COVID-19 adverse outcomes by first regulating the renin angiotensin system (RAS). Recent studies on animal in which acute respiratory distress syndrome (ARDS) was induced, showed that vitamin D lead to pulmonary permeability reduction by modulating RAS activity as well as the expression of the angiotensin-2 converting enzyme (ACE2). During COVID-19, downregulation of ACE2 leads to cytokine storm in the host, causing ARDS. In contrast, an experimental study conducted on mice in which ARDS was induced chemically, revealed that vitamin D admiration contributed to mRNA and ACE2 proteins levels improvement, ADRS milder symptoms as well as less lung damage.

Additionally, vitamin D had shown antiviral effects on several previous studies, that though to be exerted either by antimicrobial peptides induction which subsequently had direct antiviral action or through immunomodulatory and anti-inflammatory effects.

In addition, vitamin D stabilizes physical barriers which prevent viruses from reaching tissues susceptible to infection. Finally, previous studies demonstrated that hypovitaminosis D is accompanied by various comorbidities including diabetes mellitus, hypertension, chronic cardiovascular and respiratory diseases, and cancers, all medical conditions that are considered risk factors of COVID-19 infection deterioration and even high mortality rate.

The objective of this study is to evaluate whether supplementation with high-dose vitamin D improves the prognosis of patients diagnosed with COVID-19 compared to a standard dose of vitamin D.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Corona Virus Infection Cytokine Storm Vitamin D Deficiency

Study Design

Study Type:

Observational

Actual Enrollment :

116 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Moderate and severe patients who were infected with SARS-CoV-2 and who were already receiving treatment with standard dose vitamin D in addition to standard COVID-19 management.
Group 2 Moderate and severe patients who were infected with SARS-CoV-2 and who were already receiving treatment with high dose vitamin Din addition to standard COVID-19 management.

Outcome Measures

Primary Outcome Measures

Duration of hospitalization [Two weeks]
Length of hospital stay
In-hospital mortality [Two weeks]
Death during hospitalization
Clinical status improvement using six category ordinal scale [Two weeks]
Change in six category ordinal scale. The categories were defined as follows: 1) patient discharged, 2) hospitalization not requiring supplemental oxygen, 3) hospitalization requiring supplemental low-flow oxygen, 4) hospitalization requiring high-flow supplemental oxygen, 5) hospitalization requiring invasive mechanical ventilation, 6) death.
Change in gas exchange [Two weeks]
Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge
Time to increase in oxygenation [48 hours]
Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)

Secondary Outcome Measures

Change in Lactate dehydrogenase (LDH) levels [Two weeks]
Change in levels of Lactate dehydrogenase (LDH) between baseline and before discharge
Change in C-reactive protein (CRP) levels [Two weeks]
Change in levels of C-reactive protein (CRP) between baseline and before discharge
Change in serum ferritin levels [Two weeks]
Change in levels of serum ferritin between baseline and before discharge
Occurrence of secondary infection [Two weeks]
Occurrence of sepsis
Occurrence of at least one severe adverse event [Two weeks]
Any serious or severe adverse event that might happens during hospital stay
Need for mechanical ventilator or intensive care unit (ICU) support [Two weeks]
Admission to ICU or usage of mechanical ventilator

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 to 65 years.
COVID-19 hospitalized patients with pneumonia confirmed by chest X-ray or CT scan.
RT-PCR Confirmed infection with COVID-19 or strongly suspected infection with pending confirmation studies.
Presence of acute respiratory distress syndrome (ARDS).
Having either peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg.

Exclusion Criteria:

Vitamin D supplementation in the previous month.
Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D.
Organ failure requiring admission to a resuscitation or high dependency unit.
Pregnant women.
Participation in another simultaneous clinical trial.