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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825393
• Other study ID #: 123456
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: April 2024
• Source: Tokat State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tokat State Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	Ferritin Level	Iron deficiency marker	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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	1 year