Fibroblast Growth Factor 23 and Sclerostin in Relation to Calcium in COVID-19 Patients

Completed

• Conditions: COVID-19

• 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.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-11
• Study Start: 2022-05-01
• Primary Completion: 2023-01-01
• Status Verified: 2023-02
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Positive COVID 19 (Mild to moderate - severe to critical).

Exclusion Criteria

• 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

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