Skip to main content
OpenTrials
Completed

NCT Number: NCT03825393

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Ferritin Level

    Time frame: 1 year

    Iron deficiency marker

Secondary outcomes

  1. Fibromyalgia Impact Questionnarie Scores

    Time frame: 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.

  2. Beck Depression Inventory

    Time frame: 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.

  3. Beck Anxiety Inventory

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tokat State Hospital

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 31, 2019
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.