- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738760
Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Please Select
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Cairo, Please Select, Egypt, 11314
- Teachers Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of hospitalization
Time Frame: Two weeks
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Length of hospital stay
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Two weeks
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In-hospital mortality
Time Frame: Two weeks
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Death during hospitalization
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Two weeks
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Clinical status improvement using six category ordinal scale
Time Frame: Two weeks
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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.
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Two weeks
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Change in gas exchange
Time Frame: Two weeks
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Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge
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Two weeks
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Time to increase in oxygenation
Time Frame: 48 hours
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Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of secondary infection
Time Frame: Two weeks
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Occurrence of sepsis
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Two weeks
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Change in Lactate dehydrogenase (LDH) levels
Time Frame: Two weeks
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Change in levels of Lactate dehydrogenase (LDH) between baseline and before discharge
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Two weeks
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Change in C-reactive protein (CRP) levels
Time Frame: Two weeks
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Change in levels of C-reactive protein (CRP) between baseline and before discharge
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Two weeks
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Change in serum ferritin levels
Time Frame: Two weeks
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Change in levels of serum ferritin between baseline and before discharge
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Two weeks
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Occurrence of at least one severe adverse event
Time Frame: Two weeks
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Any serious or severe adverse event that might happens during hospital stay
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Two weeks
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Need for mechanical ventilator or intensive care unit (ICU) support
Time Frame: Two weeks
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Admission to ICU or usage of mechanical ventilator
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Two weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Nutrition Disorders
- Shock
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- COVID-19
- Coronavirus Infections
- Vitamin D Deficiency
- Cytokine Release Syndrome
Other Study ID Numbers
- COVID-VIT-D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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