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

NCT ID: NCT05275491

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-02-01

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Mild to moderate COVID 19 patients

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.

Calcium

Intervention Type DIAGNOSTIC_TEST

Free calcium serum levels

Fibroblast growth factor 23

Intervention Type DIAGNOSTIC_TEST

Serum level

Sclerostin

Intervention Type DIAGNOSTIC_TEST

Serum level

parathyroid hormone

Intervention Type DIAGNOSTIC_TEST

serum level

Severe to critical COVID 19 patients

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.

Calcium

Intervention Type DIAGNOSTIC_TEST

Free calcium serum levels

Fibroblast growth factor 23

Intervention Type DIAGNOSTIC_TEST

Serum level

Sclerostin

Intervention Type DIAGNOSTIC_TEST

Serum level

parathyroid hormone

Intervention Type DIAGNOSTIC_TEST

serum level

Normal male subjects (Control)

Calcium

Intervention Type DIAGNOSTIC_TEST

Free calcium serum levels

Fibroblast growth factor 23

Intervention Type DIAGNOSTIC_TEST

Serum level

Sclerostin

Intervention Type DIAGNOSTIC_TEST

Serum level

parathyroid hormone

Intervention Type DIAGNOSTIC_TEST

serum level

Interventions

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Calcium

Free calcium serum levels

Intervention Type DIAGNOSTIC_TEST

Fibroblast growth factor 23

Serum level

Intervention Type DIAGNOSTIC_TEST

Sclerostin

Serum level

Intervention Type DIAGNOSTIC_TEST

parathyroid hormone

serum level

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Abdel-mageed Muhammed

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asmaa Abdelmageed Muhammed, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

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Aswan University hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

References

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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/

Reference Type BACKGROUND
PMID: 32150360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33252122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33512007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33846867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24688605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22421513 (View on PubMed)

Other Identifiers

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FGF23 in COVID-19

Identifier Type: -

Identifier Source: org_study_id

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