This study has been designed in order to decrease of serum level of TNF-alpha and disease activity index of IBD patients referring to Taleghani Hospital, Tehran, Iran. This study is a randomized, double-blind, study with control group. The study populations consist of 120 IBD patients referred to Taleghani hospital. IBD patients are diagnosed based upon clinical, endoscopic, radiological and histological criteria findings by an experienced gastroenterologist. Their serum level of 25(OH) vitD3 should be<30ng/ml. Patients with Positive anti TTG test lab, history of hypercalcemia, kidney disorders requiring dialysis and pregnant women are excluded from this study. These patients are divided into treatment and control groups in randomized, double blind. Initial level of serum 25(OH) 2D3 and level of serum TNF alpha are measured. Treatment group will take 50000 iu vitamin D, one time a week for 12 weeks. After 12 weeks serum level of 25(OH) 2D3 and serum level of TNF alpha is be measured in two groups again. The difference between first and second level TNF alpha and 25(OH) 2D3 in two groups is compared by statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122915686N1
Registration date:2013-12-29, 1392/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-29, 1392/10/08
Registrant information
Name
Mohammad Hosein Safapoor
Name of organization / entity
Research center of gastroenterology and liver disease
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2515
Email address
mh.safapoor@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of gastroenterology and liver disease
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Association between Vitamin D deficiency in patients with inflammatory bowel disease and disease activity, TNF alpha level and quality of life
Public title
Effect of vitamin D in the treatment of inflammatory bowel disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion:
IBD patients are diagnosed based upon clinical, endoscopic, radiological and histological criteria findings by an experienced gastroenterologist.
Exclusion criteria:
serum level of 25(OH)vitD3>30ng/ml; positive anti TTG test lab; history of hypercalcemia; kidney disorders requiring dialysis and pregnancy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research center of gastroenterology and liver disease
Street address
7th floor, Taleghani Hospital, velenjak, Tehran
City
Tehran
Postal code
Approval date
2013-03-15, 1391/12/25
Ethics committee reference number
669
Health conditions studied
1
Description of health condition studied
inflammatory bowel disease
ICD-10 code
k50, k51
ICD-10 code description
Crohn disease of small intestine,Ulcerative colitis
Primary outcomes
1
Description
25(OH)D3 level
Timepoint
Three months after the intervention
Method of measurement
ELISA Method ( ng/ ml)
2
Description
TNF alpha level
Timepoint
Three months after the intervention
Method of measurement
ELISA Method ( ng/ ml)
3
Description
Activity Index
Timepoint
Three months after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group receive vitamin D pearl with 50000 unit once a week up to 12 weeks.
Category
Treatment - Drugs
2
Description
The control group did not receive any medication.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital, Gastroenterology ward
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of gasteroenterology and liver disease of Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Zali
Street address
7th floor, Taleghani Hospital, Velenjak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of gasteroenterology and liver disease of Beheshti 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
Taleghani Hospital
Full name of responsible person
Dr. Mohammad Hosein Safapoor
Position
Gastroenterologist
Other areas of specialty/work
Street address
7th floor, Taleghani Hospital, Velenjak, Tehran
City
Tehran
Postal code
Phone
+98 21 2243 2515
Fax
Email
mh.safapoor@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Recearch center of Gasteroenterology and liver disease
Full name of responsible person
Dr. Hamid Asad zadeh
Position
Gastroenterologist
Other areas of specialty/work
Street address
Taleghani Hospital, Velenjak, Tehran
City
Tehran
Postal code
Phone
+98 21 2243 2515
Fax
Email
hamid.assadzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Recearch center of gasteroenterology and liver disease
Full name of responsible person
Tahereh Dadaei
Position
Researcher
Other areas of specialty/work
Street address
7th floor, Taleghani Hospital, velenjak, Tehran
City
Tehran
Postal code
Phone
Fax
Email
t_dadaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)