Assessment of Vitamin D Level in COVID-19

Covid19 Clinical Trial

— COVID19  

Official title:

Assessment of Serum Vitamin D Level in COVID-19 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949412
• Other study ID #: Soh-Med-21-06-30
• Status: Completed
• Start date: June 11, 2021
• Est. completion date: September 25, 2021

Study information

• Verified date: November 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 25, 2021
• Est. primary completion date: July 30, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Vitamin D
serum vitamin D level

Locations

Country	Name	City	State
Egypt	Mona Mohammed Abdelrahman	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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)

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.

Zapata I. Vitamin d and inflammation-potential implications for severity of COVID-19. Irish Medical Journal. 2020;113(6):1-3.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level of vitamin D in patients who infected with COVID19		during the period from the start of June 2021 to the end of July 2021