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NCT05275491 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
Serum Levels of Fibroblast Growth Factor 23 and Sclerostin in Relation to Serum Calcium Level in COVID 19 Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05275491
Other study ID # FGF23 in COVID-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date February 1, 2023

Study information
Verified date February 2023
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 66
Est. completion date February 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Calcium
Free calcium serum levels
• Fibroblast growth factor 23
Serum level
• Sclerostin
Serum level
• parathyroid hormone
serum level

Locations
Country Name City State
Egypt Aswan University hospital Aswan

Sponsors (1)
Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2022 Oct 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/ — View Citation

Demir M, Demir F, Aygun H. Vitamin D deficiency is associated with COVID-19 positivity and severity of the disease. J Med Virol. 2021 May;93(5):2992-2999. doi: 10.1002/jmv.26832. Epub 2021 Feb 9. — View Citation

di Filippo L, Doga M, Frara S, Giustina A. Hypocalcemia in COVID-19: Prevalence, clinical significance and therapeutic implications. Rev Endocr Metab Disord. 2022 Apr;23(2):299-308. doi: 10.1007/s11154-021-09655-z. Epub 2021 Apr 13. — View Citation

Lewiecki EM. Role of sclerostin in bone and cartilage and its potential as a therapeutic target in bone diseases. Ther Adv Musculoskelet Dis. 2014 Apr;6(2):48-57. doi: 10.1177/1759720X13510479. — View Citation

Quarles LD. Role of FGF23 in vitamin D and phosphate metabolism: implications in chronic kidney disease. Exp Cell Res. 2012 May 15;318(9):1040-8. doi: 10.1016/j.yexcr.2012.02.027. Epub 2012 Mar 7. — View Citation

Zhou X, Chen D, Wang L, Zhao Y, Wei L, Chen Z, Yang B. Low serum calcium: a new, important indicator of COVID-19 patients from mild/moderate to severe/critical. Biosci Rep. 2020 Nov 30;40(12):BSR20202690. doi: 10.1042/BSR20202690. Online ahead of print. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in serum calcium levels Expected lower serum calcium levels in COVID 19 patients compared to control 6 months
Primary changes in FGF23 levels Expected higher FGF23 levels in COVID 19 patients compared to control 6 months
Primary changes in sclerostin levels Expected higher sclerostin levels in COVID 19 patients compared to control 6 months
Primary Changes in parathyroid hormone levels Expected lower levels in COVID 19 patients compared to control 6 months
Secondary Relation between FGF 23 and calcium levels A negative relation is expected 6 months
Secondary Relation between sclerostin and calcium levels A negative relation is expected 6 months
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