Fibromyalgia, SecondaryNCT04892602
Fibromyalgia in Rheumatiod and Psoriatic Patients
An observational study of Fibromyalgia, Secondary, run by Sohag University at 1 site in Egypt.
Trial summary
the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum Vitamin D level in those patients Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Secondary
- What is being tested?
- Serum vitaminDlevel
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Mar 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Those patient who diagnosed as rheumatiod arthritis and psoriatic arthritis..assess serum vitamin D level
Who may be able to join
- adult onset disease any patient diagnosed as rheumatiod arthritis and psoriatic arthritis above18years old
Who cannot join
- any other autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fibromyalgia in Rheumatiod and Psoriatic Arthritis Patients:Relationshipwith Disease Activity and Serum Vitamin Dlevel
the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum Vitamin D level in those patients
- Conditions
- Fibromyalgia, Secondary
- Being tested
- Serum vitaminDlevel
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum vitaminDlevelDiagnostic test
Investigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level
| Study group | Role | What they receive |
|---|---|---|
| Rheumatiod arthritis patients | Not described Receives: Diagnostic Test: Serum vitaminDlevel | |
| Psoaritic arthritis | Not described Receives: Diagnostic Test: Serum vitaminDlevel | |
| Control group | Not described Receives: Diagnostic Test: Serum vitaminDlevel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vitamin D level
Blood test to asses hypovitaminosis in these patients
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jun 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, SecondaryStudies of the same condition, open and under way.
- More trials run by Sohag 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshimaa Hamdey Khalaf, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892602
- Sponsor's protocol ID
- Soh-Med-21-05-03
- Status last verified
- Mar 2022
- First submitted
- 16 May 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Serum Vitamin Dlevel Disease activity indice
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia in Rheumatiod and Psoriatic Arthritis Patients:Relationshipwith Disease Activity and Serum Vitamin Dlevel
- ClinicalTrials.gov ID
- NCT04892602
- Acronym / sponsor ID
- Soh-Med-21-05-03
- Conditions
- Fibromyalgia, Secondary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 May 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.
the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum Vitamin D level in those patients
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatiod arthritis patients | – | Diagnostic Test: Serum vitaminDlevel |
| Psoaritic arthritis | – | Diagnostic Test: Serum vitaminDlevel |
| Control group | – | Diagnostic Test: Serum vitaminDlevel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Those patient who diagnosed as rheumatiod arthritis and psoriatic arthritis..assess serum vitamin D level
Key inclusion criteria (1 listed)
- adult onset disease any patient diagnosed as rheumatiod arthritis and psoriatic arthritis above18years old
Key exclusion criteria (1 listed)
- any other autoimmune diseases
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 |
|---|---|---|
| Serum vitaminDlevelInvestigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level | Diagnostic test | Control group, Psoaritic arthritis, Rheumatiod arthritis patients |
Primary outcome
Serum vitamin D level
Time frame: One year
Blood test to asses hypovitaminosis in these patients
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 7 Apr 2022.
- Individual participant dataSharing planned: Undecided. Serum Vitamin Dlevel Disease activity indice
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibromyalgia, Secondary, run by Sohag 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 1 inclusion and 1 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 7 Apr 2022. 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?
Serum vitamin D level (time frame: One year). 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 7 Apr 2022.