Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03825393
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sevil Okan, 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.

Condition or disease
Fibromyalgia

Detailed Description:
This sectional study included 100 patients with non-anemic 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia




Primary Outcome Measures :
  1. Pitsburgh sleep quality index [ Time Frame: 1 year ]
    Sleep assesment questionnarie

  2. Ferritin level [ Time Frame: 1 year ]
    Iron deficiency marker


Secondary Outcome Measures :
  1. Fibromyalgia impact questionnarie scores [ Time Frame: 1 year ]
    Fibromyalgia patients' physical performance assesment

  2. Beck depression inventory [ Time Frame: 1 year ]
    Depression level measurement

  3. Beck anxiety inventory [ Time Frame: 1 year ]
    Anxiety status assesment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825393


Sponsors and Collaborators
Tokat State Hospital
Investigators
Layout table for investigator information
Principal Investigator: sevil okan Doctor

Layout table for additonal information
Responsible Party: Sevil Okan, principal investigator, Tokat State Hospital
ClinicalTrials.gov Identifier: NCT03825393     History of Changes
Other Study ID Numbers: 123456
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sevil Okan, Tokat State Hospital:
Fibromyalgia Syndrome, Ferritin, Sleep

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases