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

February 13, 2023 updated by: Asmaa Abdel-mageed Muhammed, Aswan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Aswan, Egypt, 81511
        • Aswan university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Calcium
Free calcium serum levels
Diagnostic test: Fibroblast growth factor 23
Serum level
Diagnostic test: Sclerostin
Serum level
Diagnostic test: parathyroid hormone
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.
Diagnostic test: Calcium
Free calcium serum levels
Diagnostic test: Fibroblast growth factor 23
Serum level
Diagnostic test: Sclerostin
Serum level
Diagnostic test: parathyroid hormone
serum level
Normal male subjects (Control)
Diagnostic test: Calcium
Free calcium serum levels
Diagnostic test: Fibroblast growth factor 23
Serum level
Diagnostic test: Sclerostin
Serum level
Diagnostic test: parathyroid hormone
serum level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum calcium levels
Time Frame: 6 months
Expected lower serum calcium levels in COVID 19 patients compared to control
6 months
changes in FGF23 levels
Time Frame: 6 months
Expected higher FGF23 levels in COVID 19 patients compared to control
6 months
changes in sclerostin levels
Time Frame: 6 months
Expected higher sclerostin levels in COVID 19 patients compared to control
6 months
Changes in parathyroid hormone levels
Time Frame: 6 months
Expected lower levels in COVID 19 patients compared to control
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between FGF 23 and calcium levels
Time Frame: 6 months
A negative relation is expected
6 months
Relation between sclerostin and calcium levels
Time Frame: 6 months
A negative relation is expected
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2022

Primary Completion (ACTUAL)

January 1, 2023

Study Completion (ACTUAL)

February 1, 2023

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (ACTUAL)

March 11, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGF23 in COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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