Covid19NCT04709744
Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic
An observational study of Covid19, run by Mansoura University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Vitamin D and ELISA
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SLE patients infected with COVID-19
Who may be able to join
- - SLE patients previously diagnosed
- Patients are not suffering from malignancies.
- Patients have no organ failure nor uncontrolled medical illness.
- Recent COVID-19 infection
Who cannot join
- - Pregnant, lactating females
- Concurrent malignancies
- Patients with other autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Serum Vitamin D level
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
ELISADiagnostic test
Measure vitamin D level
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin D; Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of serum vitamin D in SLE infected with COVID-19
Measurement of serum vit D level (ng/ml)
Measured: 6 months
Secondary outcomes (1)
Vitamin D level with COVID-19 severity
Level of serum vitamin D (ng/ml) in mild, moderate and sever COVID-19
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Apr 2020
- Primary completion25 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Adel Abdelsalam Hussein, Mansoura University
- Investigators
- yasmin ElbaiomyAdel, MD, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709744
- Sponsor's protocol ID
- RP.21.01.91
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04709744
- Acronym / sponsor ID
- RP.21.01.91
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLE patients | – | Drug: Vitamin D, Diagnostic Test: ELISASLE 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SLE patients infected with COVID-19
Key inclusion criteria (4 listed)
- - SLE patients previously diagnosed
- Patients are not suffering from malignancies.
- Patients have no organ failure nor uncontrolled medical illness.
- Recent COVID-19 infection
Key exclusion criteria (3 listed)
- - Pregnant, lactating females
- Concurrent malignancies
- Patients with other autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Serum Vitamin D levelImpact 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 | Drug | SLE patients |
| ELISAMeasure vitamin D level | Diagnostic test | SLE patients |
Primary outcome
Level of serum vitamin D in SLE infected with COVID-19
Time frame: 6 months
Measurement of serum vit D level (ng/ml)
1 secondary outcome
Vitamin D level with COVID-19 severity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yasmin ElbaiomyAdel, MD principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of serum vitamin D in SLE infected with COVID-19 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.