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

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT03825393
• Lead Sponsor: Tokat State Hospital

Brief Summary

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2019-01-01
• Study First Submitted: 2019-01-26
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Results First Submitted: 2019-05-26
• Results First Submitted QC: 2020-04-04
• Results First Posted: 2020-04-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ferritin Level	1 year	Iron deficiency marker
Pitsburgh Sleep Quality Index	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.

Secondary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnarie Scores	1 year	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.
Beck Depression Inventory	1 year	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.
Beck Anxiety Inventory	1 year	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