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

NCT04709744 | Completed FDA Drug FDA Device

• 1 other identifier: RP.21.01.91
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Level of serum vitamin D in SLE infected with COVID-19

  Measurement of serum vit D level (ng/ml)

  6 months

Secondary Outcomes (1)

• Vitamin D level with COVID-19 severity

  6 months

Other Outcomes (4)

• Impact of serum vit D level in SLE patients on duration of COVID-19 disease course

  6 months

• Impact of prior chloroquine on COVID-19 disease outcomes

  6 months

• Serum vitamin D level and development of fatigue

  6 months

Study Arms (1)

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; Diagnostic Test: ELISA

Interventions

Vitamin D DRUG

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

Also known as: Serum Vitamin D level

SLE patients

ELISA DIAGNOSTIC_TEST

Measure vitamin D level

SLE patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SLE patients infected with COVID-19

You may qualify if:

• \- SLE patients previously diagnosed
• Patients are not suffering from malignancies.
• Patients have no organ failure nor uncontrolled medical illness.
• Recent COVID-19 infection

You may not qualify if:

• \- Pregnant, lactating females
• Concurrent malignancies
• Patients with other autoimmune disease

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, DK, 35516, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample for Vitamin D level by ELISA

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• yasmin ElbaiomyAdel, MD

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Rheumatology and Rehabilitation

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 14, 2021
• Study Start: April 1, 2020
• Primary Completion: December 25, 2020
• Study Completion: December 30, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)