Clinical trial NCT05275491: Fibroblast Growth Factor 23 and Sclerostin in Relation to Calcium in COVID-19 Patients
Official title: Serum Levels of Fibroblast Growth Factor 23 and Sclerostin in Relation to Serum Calcium Level in COVID 19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Hypocalcemia
Fibroblast growth factor 23 (FGF23)
Sclerostin
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (Group A): Mild to moderate COVID 19 patients. (Group B): Severe to critical COVID 19 patients. (Group C): Normal male subjects (Control)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in serum calcium levels
timeFrame: 6 months
measure: changes in FGF23 levels
timeFrame: 6 months
measure: changes in sclerostin levels
timeFrame: 6 months
measure: Changes in parathyroid hormone levels
timeFrame: 6 months
Secondary outcomes:
measure: Relation between FGF 23 and calcium levels
timeFrame: 6 months
measure: Relation between sclerostin and calcium levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University hospital
Study officials:
affiliation: Aswan University Hospital
name: Asmaa Abdelmageed Muhammed, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
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.
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.
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.
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.
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.