Effect of vitamin D on serum levels of Asymmetric dimethylarginine and immune system cytokines, and Cathelicidin gene expression in Ulcerative Colitis patients
This project will be done to evaluate the effect of Vitamin D3 on some biological outcomes in Ulcerative Colitis Patients. The outcomes include ADMA, IL-4, IL-20-IL-12, TNF-alpha, INF-gamma, hs-CRP, PTH and 25-OH-vitamin d3 serum levels and LL-37 gene expression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062318207N1
Registration date:2014-12-18, 1393/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-18, 1393/09/27
Registrant information
Name
Amrollah Sharifi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 583 6558
Email address
a_sharifi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-11-16, 1393/08/25
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on serum levels of Asymmetric dimethylarginine and immune system cytokines, and Cathelicidin gene expression in Ulcerative Colitis patients
Public title
Effect of vitamin D on serum levels of Asymmetric dimethylarginine and immune system cytokines, and Cathelicidin gene expression in Ulcerative Colitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ulcerative Colitis patients according to examinations, Colonoscopy, biopsy and medical history endorsed by specialized physician; Remission phase (mild and moderate, not active); Voluntary attendance; Age between 18 to 50 years; Body mass index between 18.5 to 30 kg/m2
Exclusion criteria:
Relapse phase patients; Pregnant and lactating women; Patients who receive Anti-TNF-alpha drugs like Infliximab and patients who take Cyclosporine; Patints who have received any form of vitamin D 3 months before intervention
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods street, Keshavarz Blvd, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-09-22, 1393/06/31
Ethics committee reference number
9021324004-1
Health conditions studied
1
Description of health condition studied
Ulcerative Colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Serum level Tumor Necrosis Factor alpha (TNF-α)
Timepoint
Before an 3 months after intervention
Method of measurement
ELISA kit
2
Description
Serum level of Asymmetric dimethylarginine (ADMA)
Timepoint
Before an 3 months after intervention
Method of measurement
ELISA kit
3
Description
Serum level of Interferon gamma (IFN-γ)
Timepoint
Before an 3 months after intervention
Method of measurement
ELISA kit
4
Description
Serum level of Interleukin 4 (IL-4)
Timepoint
Before an 3 months after intervention
Method of measurement
ELISA kit
5
Description
Serum level of Interleukin 10 (IL-10)
Timepoint
Before an 3 months after intervention
Method of measurement
ELISA kit
6
Description
Serum level of Interleukin 12 (IL-12)
Timepoint
Before an 3 months after intervention
Method of measurement
ELISA kit
7
Description
Serum level hs-CRP
Timepoint
Before an 3 months after intervention
Method of measurement
ELISA kit
8
Description
Cathelicidin (LL-37) gene expression
Timepoint
Before an 3 months after intervention
Method of measurement
qRT-PCR
9
Description
Added at 2017-04-15: CD40L (CD154) gene expression (Fold change)
Timepoint
Added at 2017-04-15: 3 months after the intervention
Method of measurement
Added at 2017-04-15: qRT-PCR
Secondary outcomes
1
Description
Serum Total Calcium
Timepoint
Before and 3 months after intervention
Method of measurement
Calcium Arsenazo III Reagent
2
Description
Dietary intake of Energy, Charbohydrate, Protein and Fat
Timepoint
Before and 3 months after intervention
Method of measurement
Three days 24-hour food recall
3
Description
Body Mass Index
Timepoint
Before and 3 months after intervention
Method of measurement
ُScale; Stadiometer; calculation
4
Description
Body temperature
Timepoint
Before and 3 months after intervention
Method of measurement
Thermometer
5
Description
Hemoglobin
Timepoint
Before and 3 months after intervention
Method of measurement
Photometric detection of cyanmetahemoglobin
6
Description
Serum Level of 25-Hydroxy Vitamin D3
Timepoint
Before and 3 months after intervention
Method of measurement
Elisa kit
7
Description
Serum level of Parathyroid Hormone (PTH)
Timepoint
Before and 3 months after intervention
Method of measurement
Elisa kit
8
Description
Systolic and diastolic blood pressure
Timepoint
Before and 3 months after intervention
Method of measurement
Sphygmomanometer
9
Description
Beck Depression score
Timepoint
Before and 3 months after intervention
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
1 ml 300000 Iu vitamin D3 injection
Category
Treatment - Drugs
2
Description
1 ml normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Rostam-Abadi
Street address
Ghods St, Keshavarz Blvd, Tehran University of Medical Sciences, Vice-chancelor for research
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
Golestan University of Medical Sciences
Full name of responsible person
Amrollah Sharifi
Position
PhD in Nutritional Sciences (Minor: Epidemiology), Assistant professor at Golestan University of Med
Other areas of specialty/work
Street address
First of the Shastkola road, Health school, Golestn University of Medical Sciences, Gorgan, Iran
City
Gorgan
Postal code
Phone
+98 935 583 6558
Fax
Email
a.sharifi1983@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad-Javad Hossain-Zadeh Attar
Position
Associated Professor, MD-PhD in Nutrition
Other areas of specialty/work
Street address
Hojjat-Dost St, Naderi St, Keshavarz Blvd, Tehran University of Medical Sciences, Faculty of Nutrition
City
Tehran
Postal code
Phone
+98 21 8895 5698
Fax
Email
hosseinzadeh.mdphd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amrollah Sharifi
Position
PhD in Nutrition
Other areas of specialty/work
Street address
City
Gorgan
Postal code
Phone
+98 912 610 3584
Fax
Email
a.sharifi1983@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)