Effect of vitamin B12 on pain and psychological symptoms of Fibromyalgia patients

Phase 3

• Conditions: Fibromyalgia.; Fibromyalgia; M79.7

• Registration Number: IRCT20200920048782N1
• Lead Sponsor: Guilan university of medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients with fibromyalgia diagnosis based on a rheumatologist's opinion
Fulfilled American college of rheumatology 2016 (ACR 2016)

Exclusion Criteria

Patients under 18 years old
Being pregnant or breast feeding
Patients suffering from comorbidities with chronic pain or inflammation(e.g., recent trauma, malignancy, other rheumatic diseases, celiac disease, inflammatory bowel disease)
Patients with psychological disorders except depression and anxiety
Patients with history of gastrectomy or bypass surgery
Patients with vegeterian diet
Patients without consent to participate the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease severity. Timepoint: Before intervention and 50 days after intervention. Method of measurement: Revised Fibromyalgia Impact Questionnaire.;Psychological symptom. Timepoint: Before intervention and 50 days after intervention. Method of measurement: Hospital anxiety and depression scale.;Pain intensity. Timepoint: Before intervention and 50 days after intervention. Method of measurement: Visual analogue scale.;Health related quality of life. Timepoint: Before intervention and 50 days after intervention. Method of measurement: Short-Form Health Survey.