Effect of vitamin B6 in treatment of fibromyalgia

Comparison the effectiveness of vitamin B6 and placebo in pain, psychological symptoms and inflammatory biomarkers of patients with fibromyalgia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200920048782N2

Enrollment

Registered

2021-10-04

Start date

2021-09-23

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia. Fibromyalgia

Interventions

Intervention 1: Intervention group: Patients will receive pills of vitamin B6 (40mg, Iran homone company) twice daily, for 60 days. Intervention 2: Control group: Patients will receive pills with same

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with fibromyalgia diagnosis based on a rheumatologist opinion fulfilled American college of rheumatology 2016 criteria (ACR 2016)

Exclusion criteria

Exclusion criteria: Patients under 18 years old Being pregnant or breastfeeding Patients suffering from comorbidities with chronic pain and inflammation (e.g., recent major trauma, malignancy, other rheumatic disease) Patients with psychological disorders except depression and anxiety Patients without consent to participate the study

Design outcomes

Primary

Measure	Time frame
Disease severity. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Revised fibromyalgia impact questionnaire (FIQR).;Psychological symptoms. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Hospital anxiety and depression scale (HADS).;Pain intensity. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Pain visual analogue scale (VAS).;Health related quality of life. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Short-form health survey (SF-12).;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: ESR.;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Platelet distribution width (PDW).;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Mean platelet volume (MPV).;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Neutrophil leukocyte ratio (NLR).	—

Measure

Time frame

Disease severity. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Revised fibromyalgia impact questionnaire (FIQR).;Psychological symptoms. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Hospital anxiety and depression scale (HADS).;Pain intensity. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Pain visual analogue scale (VAS).;Health related quality of life. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Short-form health survey (SF-12).;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: ESR.;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Platelet distribution width (PDW).;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Mean platelet volume (MPV).;Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Neutrophil leukocyte ratio (NLR).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaeze Gharibpoor

Rasht University of Medical Sciences

faezegharibpoor@gmail.com+98 13 3357 2495

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026