Fibromyalgia SyndromeNCT07519824
The Role of Bioelements in Fibromyalgia: Disease Activity or Depression-Anxiety?
An observational study of Fibromyalgia Syndrome and Anxiety, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome, Anxiety, Depression
- What is being tested?
- bioelements
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2016to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Mentally competent
- Women over the age of 18
Who cannot join
- Over 65 years of age
- Pregnancy
- Systemic inflammatory rheumatic disease
- Socioculturally uncommunicative individuals
- Infection
- Malignancy
Show all 9Show fewer
- Fracture
- Coagulopathy
- Peripheral circulatory disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fırat University Faculty of Medicine
Elâzığ, Centre, 23119
About this study
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?
Read the 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
- Being tested
- bioelements
- Keywords
- Fibromyalgia syndrome, iron, zinc, magnesium, selenium, depression, anxiety
- Medical subject headings
- Fibromyalgia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioelementsOther
Selenium, magnesium, iron, copper, manganese and zinc levels
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: bioelements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
Visual Analog Scale (VAS)
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
Measured: Baseline
Hospital Anxiety and Depression Scale (HAD)
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
Measured: Baseline
Nottingham Health Profile (NHP)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Dec 2016
- Primary completion1 Mar 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Firat University
- Responsible party
- Principal investigator, Ayşe Ukbe Baykut, Ankara City Hospital Bilkent
- Investigators
- Ayşe u Baykut, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519824
- Sponsor's protocol ID
- ACHBİLKENTAUBAYKUT002
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study began enrolling participants before January 1, 2019
Publications
Aydemir O. Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg. 1997;8:187-280.
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.
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.
PubMed 10826123Sarmer 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.
PubMed 11149662Price 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.
PubMed 6226917Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783Mlyniec 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.
PubMed 24948052Serefko A, Szopa A, Poleszak E. Magnesium and depression. Magnes Res. 2016 Mar 1;29(3):112-119. doi: 10.1684/mrh.2016.0407.
PubMed 27910808Kim 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.
PubMed 22022174Pickering 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.
PubMed 33260549Sendur 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.
PubMed 18496697Ozgocmen 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.
PubMed 16328420Jurado-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.
PubMed 39062116Alvarez 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.
PubMed 33915694
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bioelements in Fibromyalgia: Disease Activity or Depression-Anxiety?
- ClinicalTrials.gov ID
- NCT07519824
- Acronym / sponsor ID
- ACHBİLKENTAUBAYKUT002
- Conditions
- Fibromyalgia Syndrome, Anxiety, Depression
- Keywords
- Fibromyalgia syndrome, iron, zinc, magnesium, selenium, depression, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Firat University
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibromyalgia group | – | Other: bioelementsAfter 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. |
| control group | – | Other: bioelementsThe control group consisted of individuals with a similar age distribution, no history of chronic pain, and who did not meet the exclusion criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Mentally competent
- Women over the age of 18
Key exclusion criteria (9 listed)
- Over 65 years of age
- Pregnancy
- Systemic inflammatory rheumatic disease
- Socioculturally uncommunicative individuals
- Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioelementsSelenium, magnesium, iron, copper, manganese and zinc levels | Other | control group, fibromyalgia group |
Primary outcome
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.
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HAD)
Time frame: Baseline
Nottingham Health Profile (NHP)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Results publicationAydemir O. Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg. 1997;8:187-280.
- Results publicationAksu 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.
- Results publication: PubMed 10826123Kucukdeveci 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.
- Results publication: PubMed 11149662Sarmer 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.
- Results publication: PubMed 6226917Price 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.
- Results publication: PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Results publication: PubMed 24948052Mlyniec 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.
- Results publication: PubMed 27910808Serefko A, Szopa A, Poleszak E. Magnesium and depression. Magnes Res. 2016 Mar 1;29(3):112-119. doi: 10.1684/mrh.2016.0407.
- Results publication: PubMed 22022174Kim 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.
- Results publication: PubMed 33260549Pickering 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.
- Results publication: PubMed 18496697Sendur 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.
- Results publication: PubMed 16328420Ozgocmen 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.
- https://pubmed.ncbi.nlm.nih.gov/Link provided by the sponsor.
- Individual participant dataSharing planned: No. The study began enrolling participants before January 1, 2019
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe u Baykut principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia Syndrome and Anxiety, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ). (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07519824, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.