FibromyalgiaNCT03825393
Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome
An observational study of Fibromyalgia, run by Tokat State Hospital.
Trial summary
The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Fibromyalgia
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This sectional study included 100 female patients older than 18 years of age who presented to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.
Who may be able to join
- Fibromyalgi syndrome patients
- ferritin levels were measured within the last four weeks
Who cannot join
- parenteral or enteral iron usage in last four weeks
- hemoglobin level was less than 12 g/dl
- infection
- malignity
- active inflammatory arthritis
- serious skin variations
Show all 9Show fewer
- serious peripheral vascular disease
- iron storing disorder
- pregnant or lactating patients
About this study
The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.
Read the detailed description
This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients with non anemic non FMS diagnosis whose ferritin levels were measured within the last four weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin level of <30 ng/mL was considered iron deficiency.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia Syndrome, Ferritin, Sleep
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College | |
| Control | Non-anemic women without a FMS diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pitsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes "poor" sleep from "good" sleep.
minimum score 1 maximum score 9
≥5 total points in PSQI mean "poor" sleep. <5 total points in PSQI mean good sleep.
Measured: 1 year
Ferritin Level
Iron deficiency marker
Measured: 1 year
Secondary outcomes (3)
Fibromyalgia Impact Questionnarie Scores
Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.
mimimum score 0 maximum score 100 higher scores shows poor functionality.
Measured: 1 year
Beck Depression Inventory
Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).
minimum 0 maximum 63 points higher scores mean worse outcome.
Measured: 1 year
Beck Anxiety Inventory
Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).
minimum 0 maximum 63 points higher scores mean worse outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sevil Okan, Tokat State Hospital
- Investigators
- sevil okan, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825393
- Sponsor's protocol ID
- 123456
- Status last verified
- Apr 2024
- First submitted
- 26 Jan 2019
- Last updated
- 10 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT03825393
- Acronym / sponsor ID
- 123456
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia Syndrome, Ferritin, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tokat State HospitalOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.
Detailed description
This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients with non anemic non FMS diagnosis whose ferritin levels were measured within the last four weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin level of <30 ng/mL was considered iron deficiency.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | –Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College |
| Control | – | –Non-anemic women without a FMS diagnosis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This sectional study included 100 female patients older than 18 years of age who presented to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.
Key inclusion criteria (2 listed)
- Fibromyalgi syndrome patients
- ferritin levels were measured within the last four weeks
Key exclusion criteria (9 listed)
- parenteral or enteral iron usage in last four weeks
- hemoglobin level was less than 12 g/dl
- infection
- malignity
- active inflammatory arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pitsburgh Sleep Quality Index
Time frame: 1 year
Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes "poor" sleep from "good" sleep. minimum score 1 maximum score 9 ≥5 total points in PSQI mean "poor" sleep. <5 total points in PSQI mean good sleep.
Ferritin Level
Time frame: 1 year
Iron deficiency marker
3 secondary outcomes
Fibromyalgia Impact Questionnarie Scores
Time frame: 1 year
Beck Depression Inventory
Time frame: 1 year
Beck Anxiety Inventory
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
sevil okan principal investigator
Doctor
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Tokat State Hospital.
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 2 inclusion and 9 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pitsburgh Sleep Quality Index (time frame: 1 year). The study lists 2 primary outcomes in all. 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 10 Apr 2024.