Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 3:52 PM
Study NCT ID:
NCT07013305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre- and Post-Treatment Investigation of B12 and Folic Acid (Folate) Levels in Patients Receiving Antiepileptic (Anticonvulsant) Treatment for Fibromyalgia: Retrospective Study
Sponsor:
Gaziosmanpasa Research and Education Hospital
Organization:
Study Overview
Official Title:
Pre- and Post-Treatment Investigation of B12 and Folic Acid (Folate) Levels in Patients Receiving Antiepileptic (Anticonvulsant) Treatment for Fibromyalgia: Retrospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia is a rheumatological disorder characterised by chronic widespread body pain, second most common after osteoarthritis. The overall prevalence is 2-8% and it is more common in women. Diffuse body pain, fatigue, sleep and cognitive dysfunction occur. The etiology of fibromyalgia is multifactorial and occurs due to central and peripheral pain mechanisms that occur with neuroendocrine imbalance due to psychological and physical stress in people with genetic predisposition. The diagnostic criteria for fibromyalgia were updated by the American College of Rheumatology in 2016 to include a widespread body pain scale and a symptom severity scale.
Fibromyalgia treatment consists of drug (antidepressants and antiepileptics) and non-drug treatments. Pregabalin is also used in the treatment of epilepsy by blocking and modulating the α2 δ subunit of voltage-dependent calcium channels. There are studies showing that antiepileptics cause folate and vitamin B12 deficiency in epilepsy patients. In our study, we aimed to retrospectively investigate vitamin B12 and folic acid levels before and after treatment in patients with fibromyalgia using antiepileptics (anticonvulsants).
Fibromyalgia treatment consists of drug (antidepressants and antiepileptics) and non-drug treatments. Pregabalin is also used in the treatment of epilepsy by blocking and modulating the α2 δ subunit of voltage-dependent calcium channels. There are studies showing that antiepileptics cause folate and vitamin B12 deficiency in epilepsy patients. In our study, we aimed to retrospectively investigate vitamin B12 and folic acid levels before and after treatment in patients with fibromyalgia using antiepileptics (anticonvulsants).
Detailed Description:
After the acceptance of the study (after obtaining ethics committee approval), patients who have been followed up for at least 6 months in the physical medicine and rehabilitation outpatient clinic with a diagnosis of fibromyalgia and who use pregabalin will be evaluated retrospectively (1-year records). Blood vitamin B12 and folate (folic acid) levels of the patients before and after antiepileptics (anticonvulsants). use will be determined. Patients will be evaluated whether there is a change in vitamin B12 and folic acid levels due to antiepileptics (anticonvulsants) drug use.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: