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

NCT ID: NCT04738760

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-08-01

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.

Conditions

Covid19; Corona Virus Infection; Cytokine Storm; Vitamin D Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 65 years.

2. COVID-19 hospitalized patients with pneumonia confirmed by chest X-ray or CT scan.

3. RT-PCR Confirmed infection with COVID-19 or strongly suspected infection with pending confirmation studies.

4. Presence of acute respiratory distress syndrome (ARDS).

5. 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

1. Vitamin D supplementation in the previous month.

2. Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D.

3. Organ failure requiring admission to a resuscitation or high dependency unit.

4. Pregnant women.

5. Participation in another simultaneous clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Misr International University

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Neven Sarhan

Lecturer at Faculty of Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neven Sarhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Locations

Teachers Hospital

Cairo, Please Select, Egypt

Countries

Egypt

Other Identifiers

COVID-VIT-D

Identifier Type: -

Identifier Source: org_study_id