The aim of this clinical trial is to evaluate the effects of vitamin A supplementation on immune indices in patients with ulcerative colitis. In this study, 40 patients with ulcerative colitis who referred to the Sheikh Alryys clinic and meet inclusion and exclusion criteria will be recruited. The patients will receive two injections of vitamin A with two weeks intervals (each time 50000 IU). Food frequency and clinical questionnaires and serum retinol levels, interleukin 4, 10, and 12, acute phase protein CRP, and the number of lymphocytes TCD4 will be measured before and 45 days after beginning of the intervention and will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008184105N3
Registration date:2010-09-16, 1389/06/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-16, 1389/06/25
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of Medical Sciences, Nutrition Research Center, Faculty of Health and Nutrition, Gastroenterology Research Center, Imam Reza hospital
Expected recruitment start date
2010-04-22, 1389/02/02
Expected recruitment end date
2010-08-06, 1389/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin A supplementation on immune system indices in patients with ulcerative colitis
Public title
Effect of vitamin A supplementation on immune system indices in patients with ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of ulcerative colitis, age range 20 to 45 years, signing consent, receiving similar medications during 6 months prior to the intervention, (a Salazyny drugs: Azathioprine, sulfasalazine)
Exclusion criteria: Presence of any autoimmune disease (disease, MS, lupus erythematosus), chronic exposure to any infectious disease, inflammation, diabetes or cancer, consumption of any food supplement such as multivitamin- mineral, vitamin A, zinc and vitamin D and omega-3), use any type of anti-inflammatory drugs such as NSAIDS and immunosuppressives (cyclosporine and ...), pregnancy or intention to become pregnant, any surgery during six months prior to the study, BMI more than 30
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
empty
Ethics committee reference number
8915
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51.1
ICD-10 code description
Ulcerative (chronic) ileocolitis
2
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51.0
ICD-10 code description
Ulcerative (chronic) enterocolitis
3
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51.2
ICD-10 code description
Ulcerative (chronic) proctitis
4
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51.3
ICD-10 code description
Ulcerative (chronic) rectosigmoiditis
Primary outcomes
1
Description
CD4 lymphocyte count
Timepoint
before & after (day 0 & 45)
Method of measurement
flowcytometery
2
Description
proinflammatory cytokine (IL12)
Timepoint
before & after (day 0 & 45)
Method of measurement
ELISA
3
Description
acute phase protein(hs-CRP)
Timepoint
before & after (day 0 & 45)
Method of measurement
turbidometeric
4
Description
anti inflammatory cytokine(IL10 & IL4)
Timepoint
before & after (day 0 & 45)
Method of measurement
ELISA
5
Description
serum retinol
Timepoint
before & after (day 0 & 45)
Method of measurement
HPLC
Secondary outcomes
1
Description
clinical symotoms
Timepoint
before & after (day 0 & 45)
Method of measurement
trouvel witt index
2
Description
food intake habits & dietary intake
Timepoint
before & after (day 0 & 45)
Method of measurement
FFQ & dietary record (3 days)
Intervention groups
1
Description
Vitamin A supplement, as injections, twice (14 days interval), 50000 IU per injection
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykho al Rayys clinic
Full name of responsible person
Dr M.H, Soomi
Street address
Azadi avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr ostadrahimi
Street address
Vice chancellor for research of 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
Deputy of Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Nutrition research center
Full name of responsible person
Dr Ostadrahimi
Street address
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
Nutrition research center
Proportion provided by this source
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
3
Sponsor
Name of organization / entity
Gastroentrology & Liver Research Center
Full name of responsible person
Dr M.H. Soomi
Street address
Imam reza hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gastroentrology & Liver Research Center
Proportion provided by this source
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ostadrahimi
Position
Assistant Professor
Other areas of specialty/work
Street address
Health & Nutrition Faculty of Tabriz Medical Science University
City
Tabriz
Postal code
Phone
+98 41 1335 7581
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Nasim Abedi Manesh
Position
Student
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 41 1380 2161
Fax
Email
an_abedymanesh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)