Fibroblast Growth Factor 23 and Sclerostin in Relation to Calcium in COVID-19 Patients
- Conditions
- COVID-19
- Interventions
- Diagnostic Test: CalciumDiagnostic Test: Fibroblast growth factor 23Diagnostic Test: SclerostinDiagnostic Test: parathyroid hormone
- Registration Number
- NCT05275491
- Lead Sponsor
- Aswan University Hospital
- Brief Summary
Hypocalcemia is associated with COVID-19 patients and is linked to poor prognosis, Fibroblast growth factor 23 (FGF23) and Sclerostin inhibit vitamin D activation and are linked to hypocalcemia.
Levels of FGF23 and Sclerostin in COVID-19 patients will be detected and correlated to calcium levels.
- Detailed Description
COVID 19 is a current worldwide pandemic caused by severe acute respiratory syndrome coronavirus 2 "SARS-CoV-2". Hypovitaminosis D and hypocalcaemia have been reported to be associated with COVID 19 infection, they are considered good biomarkers of clinical severity of COVID 19. Poor prognosis related to hypocalcemia is increased in elderly patients.
Fibroblast growth factor 23 and sclerostin are secreted from the bone, they decrease active vitamin D levels. Their levels and their relation to calcium levels in COVID-19 patients will be detected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 66
- Positive COVID 19 (Mild to moderate - severe to critical).
- known diagnosis of CKD.
- Known parathyroid disease.
- Use of phosphate binder therapy within the past 3 months.
- Use of calcium therapy within the past 3 months
- Treatment with 25(OH) vitamin D or 1,25 (OH)(2) D
- Underlying metabolic bone disease.
- Underlying renal phosphate wasting disorder.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Normal male subjects (Control) Calcium - Severe to critical COVID 19 patients parathyroid hormone According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Severe illness that show SpO2 \< 94% on room air, (PaO2/FiO2) \<300 mm Hg \& lung infiltration \> 50% with respiratory rate \> 30 breath/min. Critical illness that show respiratory failure, septic shock or multiorgan failure. Severe to critical COVID 19 patients Fibroblast growth factor 23 According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Severe illness that show SpO2 \< 94% on room air, (PaO2/FiO2) \<300 mm Hg \& lung infiltration \> 50% with respiratory rate \> 30 breath/min. Critical illness that show respiratory failure, septic shock or multiorgan failure. Mild to moderate COVID 19 patients Calcium According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Mild illness that show symptoms like fever, cough, nausea, vomiting, sore throat, loss of taste \& smell but don't show dyspnea or abnormal chest imaging. Moderate illness that show clinical or radiological lower respiratory disease with SpO2 \> 94% on room air. Mild to moderate COVID 19 patients Sclerostin According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Mild illness that show symptoms like fever, cough, nausea, vomiting, sore throat, loss of taste \& smell but don't show dyspnea or abnormal chest imaging. Moderate illness that show clinical or radiological lower respiratory disease with SpO2 \> 94% on room air. Normal male subjects (Control) Sclerostin - Mild to moderate COVID 19 patients Fibroblast growth factor 23 According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Mild illness that show symptoms like fever, cough, nausea, vomiting, sore throat, loss of taste \& smell but don't show dyspnea or abnormal chest imaging. Moderate illness that show clinical or radiological lower respiratory disease with SpO2 \> 94% on room air. Severe to critical COVID 19 patients Sclerostin According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Severe illness that show SpO2 \< 94% on room air, (PaO2/FiO2) \<300 mm Hg \& lung infiltration \> 50% with respiratory rate \> 30 breath/min. Critical illness that show respiratory failure, septic shock or multiorgan failure. Mild to moderate COVID 19 patients parathyroid hormone According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Mild illness that show symptoms like fever, cough, nausea, vomiting, sore throat, loss of taste \& smell but don't show dyspnea or abnormal chest imaging. Moderate illness that show clinical or radiological lower respiratory disease with SpO2 \> 94% on room air. Severe to critical COVID 19 patients Calcium According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Severe illness that show SpO2 \< 94% on room air, (PaO2/FiO2) \<300 mm Hg \& lung infiltration \> 50% with respiratory rate \> 30 breath/min. Critical illness that show respiratory failure, septic shock or multiorgan failure. Normal male subjects (Control) Fibroblast growth factor 23 - Normal male subjects (Control) parathyroid hormone -
- Primary Outcome Measures
Name Time Method changes in FGF23 levels 6 months Expected higher FGF23 levels in COVID 19 patients compared to control
Changes in parathyroid hormone levels 6 months Expected lower levels in COVID 19 patients compared to control
Changes in serum calcium levels 6 months Expected lower serum calcium levels in COVID 19 patients compared to control
changes in sclerostin levels 6 months Expected higher sclerostin levels in COVID 19 patients compared to control
- Secondary Outcome Measures
Name Time Method Relation between FGF 23 and calcium levels 6 months A negative relation is expected
Relation between sclerostin and calcium levels 6 months A negative relation is expected
Trial Locations
- Locations (1)
Aswan University hospital
🇪🇬Aswan, Egypt