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

Completed

• Conditions: Covid19
• Interventions: Drug: Vitamin D; Diagnostic Test: ELISA

• Registration Number: NCT04709744
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-12-25
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SLE patients	ELISA	SLE patients were presented to chest outpatient clinic and emergency hospital, Mansoura University with manifestation suggesting COVID-19 infection. Vit D was measured in serum by ELISA. Vit D was added to anti COVID-19.
SLE patients	Vitamin D	SLE patients were presented to chest outpatient clinic and emergency hospital, Mansoura University with manifestation suggesting COVID-19 infection. Vit D was measured in serum by ELISA. Vit D was added to anti COVID-19.

Primary Outcome Measures

Name	Time	Method
Level of serum vitamin D in SLE infected with COVID-19	6 months	Measurement of serum vit D level (ng/ml)

Secondary Outcome Measures

Name	Time	Method
Vitamin D level with COVID-19 severity	6 months	Level of serum vitamin D (ng/ml) in mild, moderate and sever COVID-19

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, DK, Egypt