fibromyalgia syndrome. Other soft tissue disorders, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Trazodone plus Vitamin D
Trazodon 25 mg daily plus pearl vitamin D 50000 unit weekly for 8 weeks. Intervention 2: Control : Tab trazodon 25mg daily.
Treatment - Drugs
Intervention group: Trazodone plus Vitamin D
Trazodon 25 mg daily plus pearl vitamin D 50000 unit weekly for 8 weeks.
Control : Tab trazodon 25mg daily
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 20-70 years old females who fill ACR criteria 2010 of fibromyalgia and 25OHD level less than 30 ng/ml. Exclusions: rheumatologic disease; metabolic bone disease; diabetes; major depression; liver diseases; chronic kidney disease; cancer; malabsorption; pregnancy; steroid user; any extra-protocol vitamin D consumption; patients who had been treated with trazodon previously with no response.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: On the day of recruitment ,4 and 8 weeks later. Method of measurement: SF36 and EQ-5D questionere. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rising of 25OH D level, comparison of sleep questioneer score before and after intervention in each group. Timepoint: on 1st day of recuitment, 4 and 8 weeks after intervention. Method of measurement: ELISA. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMozhdeh Zabihiyeganeh
Tehran university of medical sciences
Outcome results
None listed