Assessment of Vitamin D Level in COVID-19

NCT ID: NCT04949412

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2021-09-25

Brief Summary

his a prospective observational study will be conducted on 100 patients who were diagnosed as SARS-CoV2 positive. The data will be collected from isolation hospital in Sohag governorate during the period from the start of June 2021 to the end of July 2021. Patients will be followed up for at least one month to evaluate the prognosis.

Detailed Description

This a prospective observational study will be conducted on 100 patients who were diagnosed as SARS-CoV2 positive. The data will be collected from isolation hospital in Sohag governorate during the period from the start of June 2021 to the end of July 2021. Patients will be followed up for at least one month to evaluate the prognosis.

Inclusion criteria:

Patients with SARS-CoV2 positive PCR.

Exclusion Criteria:

Patients with chronic obstructive lung disease Chronic renal failure Patients with malabsorption Organ transplant recipient Pregnant women The study protocol will be approved by the scientific Research Ethical committee, Faculty of Medicine, Sohag University.

The Data will be collected after taken informed written consent from the patients:

Data about clinical manifestation including as fever, cough, dyspnea, fatigue and diarrhea.

Laboratory investigation:

CBC , liver function tests, CRP, D-dimer Serum creatinine, Random blood sugar, Serum ferritin and zwsVitamin D level

Assessment the severity of the disease:

Patients were classified into severe or mild cases based on results from chest radiography, clinical examination, and symptoms.

Patients with mild symptoms (i.e., fever, cough, expectoration, and other upper respiratory tract symptoms), and without abnormalities, or with mild changes on chest radiography, were classified as non-severe types. A mild change in chest radiography is defined by multiple small patchy shadows and interstitial changes, mainly in the outer zone of the lung and under the pleura.

Severe pneumonia was defined by the presence of any of the following conditions: i) significantly increased respiration rate (RR): RR ≥30 times/minute; ii) hypoxia: oxygen saturation (resting state) ≤93%; iii) blood gas analysis: partial pressure of oxygen/fraction of inspired oxygen (PaO2) /FiO2) ≤ 300 mmHg (millimeters of Mercury); or iv) the occurrence of respiratory or other organ failure that require Intensive care unit (ICU) monitoring and treatment, or shock 6.

Statistical analysis:

Continuous variables were expressed as mean ± standard deviation or median and interquartile range and compared with the student's t-test or Mann-Whitney U test according to the distribution of data. Categorical variables were presented as numbers and percentages and compared using the chi squared test or the Fisher exact test as appropriate. Spearman P rho was used to assess the relationships between serum 25OHD levels and several clinical and laboratory parameters. P value will be considered significant if it was less than 0.05.

Conditions

Covid19

Keywords

vitamin D; COVID-19; Severity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non-severe COVID19

Patients with mild symptoms (i.e., fever, cough, expectoration, and other upper respiratory tract symptoms), and without abnormalities, or with mild changes on chest radiography, were classified as non-severe types or A mild change in chest radiography is defined by multiple small patchy shadows and interstitial changes, mainly in the outer zone of the lung and under the pleura.

Vitamin D

Intervention Type: DIAGNOSTIC_TEST

serum vitamin D level

Severe Covid19

Severe pneumonia was defined by the presence of any of the following conditions: i) significantly increased respiration rate (RR): RR ≥30 times/minute; ii) hypoxia: oxygen saturation (resting state) ≤93%; iii) blood gas analysis: partial pressure of oxygen/fraction of inspired oxygen (PaO2) /FiO2) ≤ 300 mmHg (millimeters of Mercury); or iv) the occurrence of respiratory or other organ failure that require Intensive care unit (ICU) monitoring and treatment, or shock

Vitamin D

Intervention Type: DIAGNOSTIC_TEST

serum vitamin D level

Interventions

Vitamin D

serum vitamin D level

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Patients with SARS-CoV2 positive PCR

Exclusion Criteria

Patients with chronic obstructive lung disease Chronic renal failure Patients with malabsorption Organ transplant recipient Pregnant women

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mona Mohammed Abdelrhman

Mona Mohammed Abdelrhman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Haridy, Deminstrator

Role: STUDY_CHAIR

Al-Azahar University

Mohamed Mahmoud, lecturer

Role: STUDY_CHAIR

Sohag University

Ahmed Nour-Eldin, lecturer

Role: STUDY_CHAIR

Sohag University

Asmaa Khalaf, lecturer

Role: STUDY_CHAIR

Sohag University

Amira Maher, lecturer

Role: STUDY_CHAIR

Sohag University

Locations

Mona Mohammed Abdelrahman

Sohag, , Egypt

Countries

Egypt

References

Masoud HH, Zaky S, Baki AA. Management Protocol for COVID-19 Patients Version 1.4/30th May 2020 Ministry of health and population (MOHP), Egypt. 2020;(September)

Reference Type: BACKGROUND

Laird E, Rhodes J, Kenny RA. Vitamin D and Inflammation: Potential Implications for Severity of Covid-19. Ir Med J. 2020 May 7;113(5):81.

Reference Type: BACKGROUND

PMID: 32603576 (View on PubMed)

Mohammed M, Shafik NS, Maher A, Hemdan SB, Elhamed MA. Liver Injuries in COVID-19 infected patients. Sohag Medical Journal. 2020;24(2):15-19.

Reference Type: BACKGROUND

Other Identifiers

Soh-Med-21-06-30

Identifier Type: -

Identifier Source: org_study_id