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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Vitamin D; Diagnostic test: 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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 35516
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

SLE patients infected with COVID-19

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SLE patients; 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.	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; Other Names: Serum Vitamin D level; Diagnostic test: ELISA; Measure vitamin D level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of serum vitamin D in SLE infected with COVID-19	Measurement of serum vit D level (ng/ml)	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: yasmin ElbaiomyAdel, MD, Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): December 25, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: January 9, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: RP.21.01.91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes