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

NCT04738760 | Completed DMC

• 1 other identifier: COVID-VIT-D
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19; Cytokine Storm; Vitamin D

Outcome Measures

Primary Outcomes (5)

• Duration of hospitalization

  Length of hospital stay

  Two weeks

• In-hospital mortality

  Death during hospitalization

  Two weeks

• Clinical status improvement using six category ordinal scale

  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.

  Two weeks

• Change in gas exchange

  Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge

  Two weeks

• Time to increase in oxygenation

  Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)

  48 hours

Secondary Outcomes (6)

• Change in Lactate dehydrogenase (LDH) levels

  Two weeks

• Change in C-reactive protein (CRP) levels

  Two weeks

• Change in serum ferritin levels

  Two weeks

• Occurrence of secondary infection

  Two weeks

• Occurrence of at least one severe adverse event

  Two weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients received the same background treatment for 5 days, following an Institutional protocol for standard of care: hydroxychloroquine 400 mg daily, lopinavir/ritonavir 400/100 mg twice daily or/and remdisivir 200 mg LD then 100 once daily as a maintenance dose and anti-coagulation prophylaxis with enoxaparin subcutaneously once a day if D-dimmer between 500-1000 or enoxaparin therapeutic subcutaneously twice daily if D-dimmer \>1000.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator

Study Sites (1)

Teachers Hospital

Cairo, Please Select, 11314, Egypt

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Cytokine Release Syndrome; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Neven Sarhan, PhD

  Misr International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Faculty of Pharmacy

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)