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IRCT20200920048782N1 IRCT 2021-08-28 Guilan university of medical sciences Effect of vitamin B12 on pain and psychological symptoms of Fibromyalgia patients Investigating the effect of vitamin B12 on disease severity, pain intensity and psychological symptoms of Fibromyalgia patients referred to fibromyalgia clinic of Razi hospital 2021-09-06 anticipated 30 Complete https://irct.ir/trial/57920 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: this is a pre-post study. 3 Fibromyalgia. Intervention group: patients will receive 50 pearls of vitamin B12 (1000mcg, Health aid company, England) and will be instructed to use one pearl daily for 50 days.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no furthur information
public Faeze Gharibpoor
No. 33, gohari alley, moalem blv
Rasht Iran (Islamic Republic of) 4155646515 +98 13 3357 2495 faezegharibpoor@gmail.com Rasht University of Medical Sciences scientific Faeze Gharibpoor
No. 33, gohari alley, moalem blv
Rasht Iran (Islamic Republic of) 4155646515 +98 13 3357 2495 faezegharibpoor@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with fibromyalgia diagnosis based on a rheumatologist's opinion Fulfilled American college of rheumatology 2016 (ACR 2016) 18 years no limit Both 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 M79.7 Fibromyalgia Treatment - Drugs Intervention group: patients will receive 50 pearls of vitamin B12 (1000mcg, Health aid company, England) and will be instructed to use one pearl daily for 50 days. 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. Guilan university of medical sciences Approved 2021-07-28 Research Ethics Committees of Guilan university of medical sciences Student Research Committee, Deputy of Research and Technology, Namjoo St Rasht Guilan Iran (Islamic Republic of)