Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic

Covid19 Clinical Trial

Official title:

Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709744
• Other study ID #: RP.21.01.91
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of the work Impact of serum vit D level in SLE patients with COVID-19 disease on severity of infection, duration of COVID-19 disease course, fatigue development as a complication for both SLE and COVID-19 and assess impact of prior chloroquine on COVID-19 disease outcomes Patients and methods 38 SLE patients previously diagnosed and on different lines of lupus management. Participants were presented to chest outpatient clinic and emergency hospital, Mansoura University with manifestation suggesting COVID-19 infection. Serum vit D was measured in serum by ELISA.

Description:

Primary objective: assess the impact of serum vit D level in SLE patients with COVID-19 disease on severity of infection and pandemic treatment outcome.

Secondary objectives:

• Effect of serum vit D level in SLE patients on duration of COVID-19 disease course and fatigue development as a complication for both SLE and COVID-19

• Impact of prior chloroquine on COVID-19 disease outcomes

• Correlation of serum vit D level with different laboratory investigations at time of COVID-19 outbreak

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 30, 2020
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• - SLE patients previously diagnosed

• Patients are not suffering from malignancies.

• Patients have no organ failure nor uncontrolled medical illness.

• Recent COVID-19 infection

Exclusion Criteria:

• - Pregnant, lactating females

• Concurrent malignancies

• Patients with other autoimmune disease

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Vitamin D
Impact of serum vit D level in SLE patients with COVID-19 disease on severity of infection, duration of COVID-19 disease course, fatigue development as a complication for both SLE and COVID-19 and assess impact of prior chloroquine on COVID-19 disease outcomes

Diagnostic Test:
• ELISA
Measure vitamin D level

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of serum vit D level in SLE patients on duration of COVID-19 disease course	serum vit D level (ng/ml) in SLE patients and time to recovery (number of days) from COVID-19	6 months
Other	Impact of prior chloroquine on COVID-19 disease outcomes	Can prior chloroquine in SLE patients affect outcome of COVID-19 infection (recovery or die)	6 months
Other	Serum vitamin D level and development of fatigue	Basal vitamin d level (ng/ml) in SLE patients diagnosed with recent COVID-19 and development of fatigue after recovery from COVID-19 infection	6 months
Other	Correlation of serum vit D level with different laboratory investigations at time of COVID-19 outbreak	Correlation of serum vit D level (ng/ml) with ESR, CRP, serum Lymphocyte count, Ferritine, D-dimer at time of COVID-19 diagnosis	6 months
Primary	Level of serum vitamin D in SLE infected with COVID-19	Measurement of serum vit D level (ng/ml)	6 months
Secondary	Vitamin D level with COVID-19 severity	Level of serum vitamin D (ng/ml) in mild, moderate and sever COVID-19	6 months