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

Completed

• Conditions: Covid19; Corona Virus Infection; Cytokine Storm; Vitamin D Deficiency

• Registration Number: NCT04738760
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-04
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	Two weeks	Death during hospitalization
Time to increase in oxygenation	48 hours	Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)
Duration of hospitalization	Two weeks	Length of hospital stay
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Teachers Hospital; 🇪🇬 Cairo, Please Select, Egypt