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Completed

NCT Number: NCT05275491

Fibroblast Growth Factor 23 and Sclerostin in Relation to Calcium 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.

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Key information

Conditions

COVID-19 Calcium Metabolism Disorders Coronaviridae Infections Coronavirus Infections Hypocalcemia Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sclerosteosis Virus Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Aswan University hospital

Aswān, 81511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium

Diagnostic Test

Free calcium serum levels

fibroblast growth factor 23

Diagnostic Test

Serum level

Sclerostin

Diagnostic Test

Serum level

parathyroid hormone

Diagnostic Test

serum level

Primary outcomes

  1. Changes in serum calcium levels

    Time frame: 6 months

    Expected lower serum calcium levels in COVID 19 patients compared to control

  2. changes in FGF23 levels

    Time frame: 6 months

    Expected higher FGF23 levels in COVID 19 patients compared to control

  3. changes in sclerostin levels

    Time frame: 6 months

    Expected higher sclerostin levels in COVID 19 patients compared to control

  4. Changes in parathyroid hormone levels

    Time frame: 6 months

    Expected lower levels in COVID 19 patients compared to control

Secondary outcomes

  1. Relation between FGF 23 and calcium levels

    Time frame: 6 months

    A negative relation is expected

  2. Relation between sclerostin and calcium levels

    Time frame: 6 months

    A negative relation is expected

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2022
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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