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NCT Number: 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.

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Key information

Conditions

Covid19 Avitaminosis COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Cytokine Release Syndrome Cytokine Storm Deficiency Diseases Infections Inflammation Lung Diseases Malnutrition Nidovirales Infections Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Shock Systemic Inflammatory Response Syndrome Virus Diseases Vitamin D Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Teachers Hospital

Cairo, Please Select, 11314, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Duration of hospitalization

    Time frame: Two weeks

    Length of hospital stay

  2. In-hospital mortality

    Time frame: Two weeks

    Death during hospitalization

  3. Clinical status improvement using six category ordinal scale

    Time frame: 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.

  4. Change in gas exchange

    Time frame: Two weeks

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

  5. Time to increase in oxygenation

    Time frame: 48 hours

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

Secondary outcomes

  1. Change in Lactate dehydrogenase (LDH) levels

    Time frame: Two weeks

    Change in levels of Lactate dehydrogenase (LDH) between baseline and before discharge

  2. Change in C-reactive protein (CRP) levels

    Time frame: Two weeks

    Change in levels of C-reactive protein (CRP) between baseline and before discharge

  3. Change in serum ferritin levels

    Time frame: Two weeks

    Change in levels of serum ferritin between baseline and before discharge

  4. Occurrence of secondary infection

    Time frame: Two weeks

    Occurrence of sepsis

  5. Occurrence of at least one severe adverse event

    Time frame: Two weeks

    Any serious or severe adverse event that might happens during hospital stay

  6. Need for mechanical ventilator or intensive care unit (ICU) support

    Time frame: Two weeks

    Admission to ICU or usage of mechanical ventilator

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Misr International University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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