The Role of Bioelements in Fibromyalgia: Disease Activity or Depression-Anxiety?

April 2, 2026 updated by: Ayşe Ukbe Baykut, Ankara City Hospital Bilkent

The aim of this observational study was to determine the levels of serum bioelements in patients with fibromyalgia syndrome and to evaluate the relationship of these bioelements with disease activity, depression and anxiety.

primary hypothesis: Are serum bioelement levels of women with fibromyalgia syndrome different from healthy people? secondary hypothesis: Are serum bioelement levels associated with disease activity? Are serum bioelement levels associated with depression and anxiety?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia Syndrome (FMS) is a chronic painful musculoskeletal condition characterized by widespread pain, muscle tenderness, and fatigue (1). Its prevalence is between 2 and 4 percent (2). While it can occur in all ages and genders, the majority of cases are women between the ages of 30 and 50 (3). Fibromyalgia syndrome is a clinical syndrome and is diagnosed according to specific diagnostic criteria (4).

The etiology and pathophysiology of FMS are not fully understood. Genetic predisposition, traumatic, inflammatory, hormonal, and immunological factors, stress, depression, and anxiety are thought to trigger this syndrome (5). Studies have indicated that an imbalance in antioxidant enzymes plays a role in the pathogenesis of FMS (6). Bioelements such as selenium, iron, zinc, and copper are known to be required as cofactors for many antioxidant enzymes (7,8). Furthermore, FMS symptoms such as fatigue, muscle weakness, irritable bowel, and paresthesia are similar to those of magnesium deficiency. Low magnesium levels can lead to decreased energy production in the body, leading to feelings of fatigue, muscle weakness, and cramps (9,10). Furthermore, there is strong evidence that essential element deficiencies can lead to the development of depression or anxiety (11). Studies have reported a significant correlation between magnesium, iron, and zinc levels and the incidence of depressive symptoms. When magnesium is deficient, personality changes such as apathy, depression, confusion, anxiety, and delirium can be observed (12). Furthermore, serum zinc concentrations were found to be significantly lower in patients with generalized anxiety disorder compared to the control group, while serum copper, manganese, and iron levels were significantly higher (13).

Research is ongoing to elucidate the etiopathogenesis and disease activity of FMS patients. No studies have been found in the literature that have evaluated the relationship between bioelement levels and disease activity, anxiety, depression in FMS patients in the same study. The aim of this cross-sectional, single-center, controlled study was to determine serum selenium, magnesium, iron, copper, manganese, and zinc levels in patients diagnosed with FMS compared to controls, and to evaluate the relationship of these bioelements to disease activity, depression and anxiety.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Centre
      • Elâzığ, Centre, Turkey (Türkiye), 23119
        • Fırat University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

After applying the exclusion criteria, with expert diagnosis considered as the gold standard, 50 patients were selected who were diagnosed with FMS according to the 2010 FMS diagnostic criteria of the American Rheumatology College (14) with symptoms for at least 3 months, widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3-6 and SS scale score ≥ 9.

Description

Inclusion Criteria:

  • Mentally competent
  • Women over the age of 18

Exclusion Criteria:

  • Over 65 years of age
  • Pregnancy
  • Systemic inflammatory rheumatic disease
  • Socioculturally uncommunicative individuals
  • Infection
  • Malignancy
  • Fracture
  • Coagulopathy
  • Peripheral circulatory disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
fibromyalgia group
After applying the exclusion criteria, with expert diagnosis considered as the gold standard, 50 patients were selected who were diagnosed with FMS according to the 2010 FMS diagnostic criteria of the American Rheumatology College (14) with symptoms for at least 3 months, widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3-6 and SS scale score ≥ 9.
Other: bioelements
Selenium, magnesium, iron, copper, manganese and zinc levels
control group
The control group consisted of individuals with a similar age distribution, no history of chronic pain, and who did not meet the exclusion criteria
Other: bioelements
Selenium, magnesium, iron, copper, manganese and zinc levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire (FIQ).
Time Frame: Baseline
The FIQ was developed to measure functional status in patients with FMS, and its validity and reliability in the Turkish population were determined by Sarmer et al. The total score ranges from 0 to 100, with a higher score indicating greater disease impact.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Baseline
The VAS pain score was measured to determine the patients' pain level. The score ranges from 0 to 100, where '0' indicates no pain and '100' indicates unbearable pain
Baseline
Hospital Anxiety and Depression Scale (HAD)
Time Frame: Baseline
The Hospital Anxiety and Depression Scale (HAD) is a self-report measure used to determine the risk of anxiety and depression and to measure its level and severity. It consists of 14 questions, seven of which (odd numbers) address anxiety and the other seven (even numbers) address depression. The cut-off score of the Turkish form was found to be 10 for the anxiety subscale and 7 for the depression subscale
Baseline
Nottingham Health Profile (NHP)
Time Frame: Baseline
The Nottingham Health Profile (NHP) is a 38-item questionnaire covering six main headings that assesses quality of life. The maximum score is 600. Low scores indicate low impact, while high scores indicate high impact
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Collaborators

Firat University

Investigators

  • Principal Investigator: Ayşe U Baykut, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACHBİLKENTAUBAYKUT002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study began enrolling participants before January 1, 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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