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Completed

NCT Number: NCT07519824

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

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?

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Fırat University Faculty of Medicine

Elâzığ, Centre, 23119, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

bioelements

Other

Selenium, magnesium, iron, copper, manganese and zinc levels

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • Firat University

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

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.

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