- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04662437
The Status of Parathyroid Hormone Secretion in Covid-19 Patients
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34093
- Bezmialem VU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Covid-19 Patient Group
10 ml of venous blood was taken from the forearm venous vein from people in the Covid-19 Patient Group, and the level of parathyroid hormone, calcium, phosphorus, alkaline phosphatase was measured from this blood.
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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.
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Healthy Control Group
10 ml of venous blood will be taken from the forearm venous vein from the healthy control group and the parathyroid hormone, calcium, phosphorus, alkaline phosphatase level will be measured from this blood.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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White blood cells (WBC) results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum WBC results were recorded in Covid 19 patient groups.
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90 days
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Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum N/LO results were recorded in Covid 19 patient groups.
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90 days
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C-reactive protein (CRP) results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum CRP results were recorded in Covid 19 patient groups.
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90 days
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Fibrinogen results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum fibrinogen results were recorded in Covid 19 patient groups.
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90 days
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Procalcitonin results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum procalcitonin results were recorded in Covid 19 patient groups.
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90 days
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Ferritin results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum ferritin results were recorded in Covid 19 patient groups.
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90 days
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D-dimer results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum D-dimer results were recorded in Covid 19 patient groups.
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90 days
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Comparison of parathyroid hormone between groups
Time Frame: 90 days
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In the study, serum parathyroid hormone results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Comparison of calcium between groups
Time Frame: 90 days
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In the study, serum calcium results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Comparison of phosphorus between groups
Time Frame: 90 days
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In the study, serum phosphorus results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Comparison of alkaline phosphatase between groups
Time Frame: 90 days
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In the study, serum alkaline phosphatase results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Derya Özalp Çelikçi, Dr, Sancaktepe Education and Research Hospital
Publications and helpful links
General Publications
- 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. doi: 10.18632/aging.103526. Epub 2020 Jun 25.
- 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. 2021 Jan;71(1):9-13. doi: 10.1007/s12020-020-02541-9. Epub 2020 Nov 9. No abstract available.
- 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;4(8):bvaa082. doi: 10.1210/jendso/bvaa082. eCollection 2020 Aug 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08122020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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