Aim: Evaluation the effect of vitamin D supplementation on quality of life in fibromyalgia syndrome. Study populations: Patients between 20-70 years with fibromyalgia who referred to the rheumatology clinic of Firouzgar hospital. Sample size: 45 patients in each group. Inclusions: fibromyalgia patients who are vitamin D deficient .Exclusions: history of rheumatic diseases, diabetes, under treatment of psychologist. Intervention: Serum 25OH D will be measured in all patients. patients with age between 20- 70 years and serum levels of vitamin D, less than 30ng/ml and desire to stop taking sleep medications and in the loss of exclusion criteria will enter in the study and demographic information as well as questionnaires EQ-5D-3L. SF36.FIQ PSQI will be completed. Then patients will be divided into two groups. Group 1 treated with vitamin D 50000IU Weekly and Trazodon (25mg at night while sleeping) and Group 2 will receive trazodon (25mg at night while sleeping) without vitamin D . Patients will be re-evaluated 4 and 8 weeks after intervention and the level of vitamin D will be measured again, in addition to completing checklists again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100610960N2
Registration date:2012-12-31, 1391/10/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-31, 1391/10/11
Registrant information
Name
Mozhdeh Zabihiyeganeh
Name of organization / entity
Tehran university of medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1301
Email address
m-zabihi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2013-03-19, 1391/12/29
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on quality of life in fibromyalgia pateints
Public title
Effect of vitamin D on quality of life in fibromyalgia pateints
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 20 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sceinces
Street address
6 floor, Tehran university of medical sceinces, Ghods street, Keshavarz blvd.
City
Tehran
Postal code
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
1391/د/210/14835
Health conditions studied
1
Description of health condition studied
fibromyalgia syndrome
ICD-10 code
M79.7
ICD-10 code description
Other soft tissue disorders, not elsewhere classified
Primary outcomes
1
Description
Quality of life
Timepoint
On the day of recruitment ,4 and 8 weeks later
Method of measurement
SF36 and EQ-5D questionere
Secondary outcomes
1
Description
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
Intervention groups
1
Description
Intervention group: Trazodone plus Vitamin D
Trazodon 25 mg daily plus pearl vitamin D 50000 unit weekly for 8 weeks.
Category
Treatment - Drugs
2
Description
Control : Tab trazodon 25mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Mozhdeh Zabihi
Street address
Firouzgar hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
Corner of Ghoods street, Keshavarz blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Mozhdeh Zabihiyeganeh
Position
Assistant Professor of rheumatology
Other areas of specialty/work
Street address
Firouzgar hospital, Behafarin, Karimkhan Zand
City
Tehran
Postal code
Phone
+98 21 8214 1301
Fax
Email
mozhdehzabihi@gmail.com ; m-zabihi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mozhdeh Zabihiyeganeh
Position
Assistant Professor of Rheumatology
Other areas of specialty/work
Street address
Firouzgar Hospital, Behafarin, Karimkhan Zand
City
Tehran
Postal code
Phone
+98 21 8214 1301
Fax
Email
mozhdehzabihi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mozhdeh Zabihiyeganeh
Position
Assistant Professor of Rheumatology
Other areas of specialty/work
Street address
Firouzgar Hospital, Behafarin, Karimkhan Zand.
City
Tehran
Postal code
Phone
Fax
Email
mozhdehzabihi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)