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

NCT07519824 | Completed

• 1 other identifier: ACHBİLKENTAUBAYKUT002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Fibromyalgia Syndrome; Anxiety; Depression

Keywords

Fibromyalgia syndrome; iron; zinc; magnesium; selenium; depression; anxiety

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FIQ).

  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 Outcomes (3)

• Visual Analog Scale (VAS)

  Baseline

• Hospital Anxiety and Depression Scale (HAD)

  Baseline

• Nottingham Health Profile (NHP)

  Baseline

Study Arms (2)

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

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

Interventions

bioelements OTHER

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

control group; fibromyalgia group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: females who match the sex assigned to them at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Mentally competent
• Women over the age of 18

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• Firat University: collaborator

Study Sites (1)

Fırat University Faculty of Medicine

Elâzığ, Centre, 23119, Turkey (Türkiye)

Location

Related Publications (14)

• Aydemir O. Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg. 1997;8:187-280.

  RESULT

• Aksu S, Aslikurne, Düger T, Öksüz Ç, Cezmitürk, Gedizoğlu T, et al. Are results of the SF-36 health survey and the Nottingham health profile similar in migraine patients? The Pain Clinic. 2004;16(2):167-71.

  RESULT

• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

  PMID: 10826123 RESULT

• Sarmer S, Ergin S, Yavuzer G. The validity and reliability of the Turkish version of the Fibromyalgia Impact Questionnaire. Rheumatol Int. 2000 Dec;20(1):9-12. doi: 10.1007/s002960000077.

  PMID: 11149662 RESULT

• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

  PMID: 6226917 RESULT

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis care & research. 2010;62(5):600-10.

  RESULT

• Mlyniec K, Davies CL, de Aguero Sanchez IG, Pytka K, Budziszewska B, Nowak G. Essential elements in depression and anxiety. Part I. Pharmacol Rep. 2014 Aug;66(4):534-44. doi: 10.1016/j.pharep.2014.03.001. Epub 2014 Apr 2.

  PMID: 24948052 RESULT

• Serefko A, Szopa A, Poleszak E. Magnesium and depression. Magnes Res. 2016 Mar 1;29(3):112-119. doi: 10.1684/mrh.2016.0407.

  PMID: 27910808 RESULT

• Kim YS, Kim KM, Lee DJ, Kim BT, Park SB, Cho DY, Suh CH, Kim HA, Park RW, Joo NS. Women with fibromyalgia have lower levels of calcium, magnesium, iron and manganese in hair mineral analysis. J Korean Med Sci. 2011 Oct;26(10):1253-7. doi: 10.3346/jkms.2011.26.10.1253. Epub 2011 Oct 1.

  PMID: 22022174 RESULT

• Pickering G, Mazur A, Trousselard M, Bienkowski P, Yaltsewa N, Amessou M, Noah L, Pouteau E. Magnesium Status and Stress: The Vicious Circle Concept Revisited. Nutrients. 2020 Nov 28;12(12):3672. doi: 10.3390/nu12123672.

  PMID: 33260549 RESULT

• Sendur OF, Tastaban E, Turan Y, Ulman C. The relationship between serum trace element levels and clinical parameters in patients with fibromyalgia. Rheumatol Int. 2008 Sep;28(11):1117-21. doi: 10.1007/s00296-008-0593-9. Epub 2008 May 22.

  PMID: 18496697 RESULT

• Ozgocmen S, Ozyurt H, Sogut S, Akyol O. Current concepts in the pathophysiology of fibromyalgia: the potential role of oxidative stress and nitric oxide. Rheumatol Int. 2006 May;26(7):585-97. doi: 10.1007/s00296-005-0078-z. Epub 2005 Nov 20.

  PMID: 16328420 RESULT

• Jurado-Priego LN, Cueto-Urena C, Ramirez-Exposito MJ, Martinez-Martos JM. Fibromyalgia: A Review of the Pathophysiological Mechanisms and Multidisciplinary Treatment Strategies. Biomedicines. 2024 Jul 11;12(7):1543. doi: 10.3390/biomedicines12071543.

  PMID: 39062116 RESULT

• Alvarez MC, Albuquerque MLL, Neiva HP, Cid L, Rodrigues F, Teixeira DS, Monteiro D. Differences between Portuguese and Brazilian Patients with Fibromyalgia Syndrome: Exploring the Associations across Age, Time of Diagnosis, and Fatigue-Related Symptoms. Medicina (Kaunas). 2021 Apr 1;57(4):322. doi: 10.3390/medicina57040322.

  PMID: 33915694 RESULT

Related Links

• https://pubmed.ncbi.nlm.nih.gov/

MeSH Terms

Conditions

Fibromyalgia; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ayşe u Baykut

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 9, 2026
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)