The Status of Parathyroid Hormone Secretion in Covid-19 Patients

COVID-19 Infection Clinical Trial

Official title:

The Status of Parathyroid Hormone Secretion and Its Relationship With White Blood Cells, Neutrophil / Lymphocyte Ratio, c Reactive Protein, Fibrinogen, Procalcitonin, Ferritin and D-dimer in Hospitalized Covid-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662437
• Other study ID #: 08122020
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: December 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COVID-19 infection causes a hypersensitive immune reaction and widespread inflammation in various organs of the body, especially through cytokines in the lungs. This cytokine-mediated widespread inflammation can also affect the parathyroid glands, resulting in impaired parathyroid secretion.

Researchers evaluated the levels of parathyroid hormone, calcium, phosphorus, and alkaline phosphatase in patients hospitalized for COVID-19 infection. Researchers excluded patients on intensive care therapy and patients with known parathyroid disease.

The researchers examined the association of parathyroid hormone secretion with COVID-19 disease, white blood cells, neutrophil / lymphocyte ratio, C reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer in these patients. The researchers compared the parathyroid hormone level of healthy people without COVID-19 infection and known parathyroid disease with the parathyroid hormone level of Covid-19 patients.

Description:

The coronavirus-2 (SARS-COV-2) virus, which can cause severe acute respiratory syndrome through the droplet, has caused the global Coronavirus 19 (COVID-19) pandemic. COVID-19 infection can be asymptomatic or lead to serious illness and even death. This virus causes a hypersensitive immune reaction and varying degrees of widespread inflammation through cytokines in various organs of the body, mainly the lungs.

Cytokine-mediated widespread inflammation caused by the virus may also affect the parathyroid glands, causing their functions to deteriorate. Thus, it may cause changes in parathyroid hormone secretion.

The researchers evaluated the results of serum parathyroid hormone, calcium, phosphorus, alkaline phosphatase tests in patients who were symptomatic and hospitalized with COVID-19 infection. Participants also evaluated the relationship of parathormone with white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer in these patients. The researchers compared the parathyroid hormone levels of patients with COVID-19 infection with the parathyroid hormone levels of healthy individuals without COVID-19 infection and parathyroid disease. So the investigators looked for differences in parathyroid hormone levels between both groups. Researchers did not include patients in the intensive care unit and patients with known parathyroid disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 9, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• To accept research.

• Being over the age of 18.

• COVID 19 test results to be positive.

• Not taking parathyroid disease medication before.

• Receiving inpatient treatment in the COVID service in the hospital.

Exclusion Criteria:

• Not accepting research.

• Be under the age of 18.

• Negative COVID 19 test results for patients.

• COVID patients treated as outpatient.

• Parathyroid disease in the healthy control group.

Related Conditions & MeSH terms

• Alkaline Phosphatase
• Calcium
• COVID-19 Infection
• Parathyroid Gland
• Parathyroid Hormone
• Phosphorus

Intervention

Diagnostic Test:
• Venous blood was collected for biochemistry testing
From the people in the healthy control group, 10 ml of venous blood was collected from the venous vein in the forearm of all individuals in the study. Parathyroid hormone, calcium, phosphorus, alkaline phosphatase levels were measured from this blood.

Locations

Country	Name	City	State
Turkey	Bezmialem VU	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Didem Ertorul

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

di Filippo L, Formenti AM, Doga M, Frara S, Rovere-Querini P, Bosi E, Carlucci M, Giustina A. Hypocalcemia is a distinctive biochemical feature of hospitalized COVID-19 patients. Endocrine. 2020 Nov 9. doi: 10.1007/s12020-020-02541-9. [Epub ahead of print — View Citation

Somasundaram NP, Ranathunga I, Ratnasamy V, Wijewickrama PSA, Dissanayake HA, Yogendranathan N, Gamage KKK, de Silva NL, Sumanatilleke M, Katulanda P, Grossman AB. The Impact of SARS-Cov-2 Virus Infection on the Endocrine System. J Endocr Soc. 2020 Jul 2; — View Citation

Sun JK, Zhang WH, Zou L, Liu Y, Li JJ, Kan XH, Dai L, Shi QK, Yuan ST, Yu WK, Xu HY, Gu W, Qi JW. Serum calcium as a biomarker of clinical severity and prognosis in patients with coronavirus disease 2019. Aging (Albany NY). 2020 Jun 25;12(12):11287-11295. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of parathyroid hormone between groups	In the study, serum parathyroid hormone results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	Comparison of calcium between groups	In the study, serum calcium results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	Comparison of phosphorus between groups	In the study, serum phosphorus results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	Comparison of alkaline phosphatase between groups	In the study, serum alkaline phosphatase results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	White blood cells (WBC) results of Covid 19 patient group	In the study, serum WBC results were recorded in Covid 19 patient groups.	90 days
Primary	Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group	In the study, serum N/LO results were recorded in Covid 19 patient groups.	90 days
Primary	C-reactive protein (CRP) results of Covid 19 patient group	In the study, serum CRP results were recorded in Covid 19 patient groups.	90 days
Primary	Fibrinogen results of Covid 19 patient group	In the study, serum fibrinogen results were recorded in Covid 19 patient groups.	90 days
Primary	Procalcitonin results of Covid 19 patient group	In the study, serum procalcitonin results were recorded in Covid 19 patient groups.	90 days
Primary	Ferritin results of Covid 19 patient group	In the study, serum ferritin results were recorded in Covid 19 patient groups.	90 days
Primary	D-dimer results of Covid 19 patient group	In the study, serum D-dimer results were recorded in Covid 19 patient groups.	90 days