Objectives: Examining the efficacy of vitamin D supplementation in controlling Behcet’s disease activity
Design, setting and conduct: In this study a sample of 50 Behcet’s disease patients will be recruited randomly in a double blind placebo controlled study. Behcet’s disease will be diagnosed by the International Study Group criteria. The aims of the study will be explained to the patients and written informed consents will be obtained. In order to carry out the randomization process, the Randlist software will be used to enter every patient in the treatment or control groups. Participants: A sample of 50 Behcet’s disease patients diagnosed according to the International Study Group criteria
Inclusion criteria:
1. Having active Behcet’s disease: Iranian Behcet's Disease Dynamic Activity Measure (IBDDAM) of more than 2.5
Exclusion criteria:
1. Consumption of vitamin D supplements in the past 6 months
2. Pregnancy
3. Malabsorption
4. Renal failure
5. Hepatic failure
Intervention: The treatment group will receive vitamin D soft gels containing 50000 units of cholecalciferol (D-VITIN, Zahravi) every 2 weeks for 6 months. The control group will receive placebo. The disease activity will be measured by the IBDAAM three times during the study: before the intervention, 3 months after the intervention, and 6 months after the intervention.
Main outcome measures: Disease activity measured by the IBDAAM.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212216975N4
Registration date:2013-03-20, 1391/12/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-20, 1391/12/30
Registrant information
Name
Alireza Khabbazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
khabbazia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-05, 1392/01/16
Expected recruitment end date
2013-04-05, 1392/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized, double-blind controlled study of the efficacy of vitamin D supplementation compared with placebo on treatment of Behcet's disease
Public title
Vitamin D supplementation for the treatment of Behcet's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having active Behcet’s disease: Iranian Behcet's Disease Dynamic Activity Measure (IBDDAM) more than 2.5
Exclusion criteria:
1. Consumption of vitamin D supplements in the past 6 months
2. Pregnancy
3. Malabsorption
4. Renal failure
5. Hepatic failure
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In order to eliminate the possibility of any probable bias due to the awareness of the patients and assessing physicians about the type of treatment, we will perform a double blind study. Vitamin D and placebo will be encapsulated so that the patients and assessing physicians will not have any knowledge about the type of the treatment. Randomization will be performed by the Randlist software and every patient will be entered in the treatment or control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz University of Medical Sciences
Street address
Ethic committee, 4th floor, Vice chancellor for research, Faculty of medicine, Tabriz University of Medical Sciences
City
Tabriz
Postal code
5166614766
Approval date
2012-12-08, 1391/09/18
Ethics committee reference number
8305/4/5
Health conditions studied
1
Description of health condition studied
Behcet's disease
ICD-10 code
M35.2
ICD-10 code description
Behçet disease
Primary outcomes
1
Description
Behcet's disease activity
Timepoint
Before intervention, 3 and 6 months after intervention
The treatment group will receive vitamin D soft gel (D-VITIN, Zahravi) containing 50000 units of cholecalciferol [(3β,5Z,7E)-9,10-secocholesta-
5,7,10(19)-trien-3-ol] one soft gel orally after meal every 2 weeks for 6 months.
Category
Treatment - Drugs
2
Description
The control group will receive one soft gel containing placebo orally after meal every 2 weeks for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Research Team, Tabriz University of Medical Sciences
Full name of responsible person
Alireza khabbazi
Street address
Rheumatology Research Team, 4th floor, Emam Reza hospital, University street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Vice chancellor for research, 4th floor, Faculty of Medicine, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehrzad Hajiallilo
Position
Assistant professor of medicine/Rheumatologist
Other areas of specialty/work
Street address
Rheumatology Research Team, 4th floor, Emam Reza hospital
City
Tabriz
Postal code
5167747899
Phone
+98 41 1337 3966
Fax
Email
hajialilo@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rheumatology Research Team, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Khabbazi
Position
Assistant professor of medicine/Rheumatologist
Other areas of specialty/work
Street address
Rheumatology Research Team, 4th floor, Emam Reza hospital
City
Tabriz
Postal code
5167747899
Phone
+98 41 1337 3966
Fax
Email
khabbazia@tbzmed.ac.ir; dr_khabbazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Khabbazi
Position
Assistant professor of medicine/Rheumatologist
Other areas of specialty/work
Street address
Rheumatology Research Team, 4th floor, Emam Reza Hospital
City
Tabriz
Postal code
5167747899
Phone
+98 41 1337 3966
Fax
Email
khabbazia@tbzmed.ac.ir; dr_khabbazi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)