NCT07519824

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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?

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.

Conditions

• Fibromyalgia Syndrome
• Anxiety
• Depression

Interventions

Type	Name	Description
OTHER	bioelements	Selenium, magnesium, iron, copper, manganese and zinc levels

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-03-01
• Completion: 2017-04-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Turkey (Türkiye)