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CompletedNCT03825393Updated Apr 10, 2024Results posted

Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome

An observational study in Fibromyalgia, sponsored by Tokat State Hospital. Completed. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Tokat State Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
Female
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Study summary

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.

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Conditions studied

  • Fibromyalgia

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Keywords

  • Fibromyalgia Syndrome, Ferritin, Sleep
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In context

Fibromyalgia

1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.

This study's enrollment of 200 is above the median of 100 across 282 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Tokat State Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Fibromyalgi syndrome patients
  • ferritin levels were measured within the last four weeks

Exclusion criteria

Exclusion Criteria:

  • 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
  • serious peripheral vascular disease
  • iron storing disorder
  • pregnant or lactating patients
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. Ferritin Level

    Iron deficiency marker

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. 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

    Time frame: 1 year

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Results

Posted Apr 7, 2020

Participant flow

Participant flow — Overall Study
MilestoneFibromiyalgiaControl
Started100100
Completed100100
Not completed00

Outcome measures

PrimaryPitsburgh 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.

Time frame:
1 year
Reported as:
Mean · score on a questionnarie
Pitsburgh Sleep Quality Index
score on a questionnarieFibromyalgia
Pitsburgh Sleep Quality Index8.3 ± 3.77
PrimaryFerritin Level

Iron deficiency marker

Time frame:
1 year
Reported as:
Median · ng/ml
Ferritin Level
ng/mlControlFibromyalgia
Ferritin Level34.91 (17.87 to 55.12)20.95 (11.75 to 39.55)
SecondaryFibromyalgia 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.

Time frame:
1 year
Reported as:
Mean · score on a questionnarie
Fibromyalgia Impact Questionnarie Scores
score on a questionnarieFibromiyalgia
Fibromyalgia Impact Questionnarie Scores61.69 ± 17.31
SecondaryBeck 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.

Time frame:
1 year
Reported as:
Mean · score on a questionnarie
Beck Depression Inventory
score on a questionnarieFibromiyalgia
Beck Depression Inventory15.73 ± 9.76
SecondaryBeck 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

Time frame:
1 year
Reported as:
Mean · score on a questionnarie
Beck Anxiety Inventory
score on a questionnarieFibromiyalgia
Beck Anxiety Inventory22.58 ± 11.14

Adverse events

Collected over no advers event 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fibromiyalgia0/100 (0%)0/100 (0%)0/100 (0%)
Control0/100 (0%)0/100 (0%)0/100 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)FibromiyalgiaControlTotal
<=18 years000
Between 18 and 65 years100100200
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)FibromiyalgiaControlTotal
Female100100200
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)FibromiyalgiaControlTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)FibromiyalgiaControlTotal
Turkey100100200
ferritin level
ferritin level(ng/ml)FibromiyalgiaControlTotal
Median20.95 (11.75 to 39.55)34.91 (17.87 to 55.12)32.92 (14.65 to 47.35)
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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03825393
Lead sponsor
Tokat State Hospital
Responsible party
Sevil Okan (principal investigator, Tokat State Hospital) — Principal investigator
First posted
Jan 31, 2019
Start date
Jan 1, 2016
Primary completion
Jan 1, 2018
Completion
Jan 1, 2019
Results posted
Apr 7, 2020
Last update
Apr 10, 2024

Study contacts

sevil okan
principal investigator · Doctor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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