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Completed

NCT Number: NCT04709744

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University Hospital

Al Mansurah, DK, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Serum Vitamin D level

ELISA

Diagnostic Test

Measure vitamin D level

Primary outcomes

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

    Time frame: 6 months

    Measurement of serum vit D level (ng/ml)

Secondary outcomes

  1. Vitamin D level with COVID-19 severity

    Time frame: 6 months

    Level of serum vitamin D (ng/ml) in mild, moderate and sever COVID-19

Other outcomes

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

    Time frame: 6 months

    serum vit D level (ng/ml) in SLE patients and time to recovery (number of days) from COVID-19

  2. Impact of prior chloroquine on COVID-19 disease outcomes

    Time frame: 6 months

    Can prior chloroquine in SLE patients affect outcome of COVID-19 infection (recovery or die)

  3. Serum vitamin D level and development of fatigue

    Time frame: 6 months

    Basal vitamin d level (ng/ml) in SLE patients diagnosed with recent COVID-19 and development of fatigue after recovery from COVID-19 infection

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

    Time frame: 6 months

    Correlation of serum vit D level (ng/ml) with ESR, CRP, serum Lymphocyte count, Ferritine, D-dimer at time of COVID-19 diagnosis

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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