The investigation of the vitamin A supplementation on disease activity index (Mayo clinic score) in patients with ulcerative colitis.
Design
،Two-arm, parallel design randomized controlled clinical trial including intervention and placebo group, double blind and randomized
sample size: 80 patients (40 patients in each group)
clinical trial phase: 3
Randomization will be done using a computer-generated randomization charts
Settings and conduct
In the present double blind randomized controlled clinical trial, 80 patients with ulcerative colitis who will be referred to the gastroenterology clinic of Imam Reza Hospital-Tabriz were selected.
The patients will be randomly allocated to the treatment group or the placebo group. Randomization was done using a computer-generated randomization charts. The investigator as well as patients were blinded to intervention.
The sample size was calculated based 80% power and α value of 0.05, which necessitated 40 cases in each group.
The conventional treatments in both groups will be kept stable for at least a month before study entry and was allowed throughout the trial. The patients in the intervention group were supplemented with 25000 IU/day vitamin A (Zahravi Farmaco) and the patients in placebo group were received placebo for two months.
Participants/Inclusion and exclusion criteria
The symptomatic patients with mayo score of 6-12 (who are symptomatic even after treatment with oral and topical 5ASA) and aged 20-45 years old were included in the study.
The patients were excluded if they were pregnant or breastfeeding or intended to be pregnant, had other autoimmune disorders, chronic infectious disease, were using vitamin A supplements regularly and smoked.
Intervention groups
Vitamin A group: 25000 IU/day vitamin A (Zahravi Farmaco)
placebo group: placebo
Main outcome variables
Disease activity index (measured using mayo clinic score)
General information
Reason for update
Acronym
mayo score
IRCT registration information
IRCT registration number:IRCT20180520039738N1
Registration date:2018-08-12, 1397/05/21
Registration timing:registered_while_recruiting
Last update:2018-08-12, 1397/05/21
Update count:0
Registration date
2018-08-12, 1397/05/21
Registrant information
Name
Mohamadreza Rohani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 4118
Email address
mohamadreza.rohani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-10-17, 1397/07/25
Trial completion date
empty
Scientific title
:Evaluation of the effect of Vitamin A supplementation in severity of acute ulcerativecolitis
Public title
Evaluation of the effect of Vitamin A supplementation in severity of acute ulcerativecolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
symptomatic patients with mayo score of 6-12 (who are symptomatic even after treatment with oral and topical 5ASA)
aged 20-65 years old
Exclusion criteria:
being pregnant or breastfeeding or intended to be pregnant
had other autoimmune disorders,
had chronic infectious disease
were using vitamin A supplements regularly
smoked
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization was done using a computer-generated randomization charts.
Blinding (investigator's opinion)
Double blinded
Blinding description
vitamin A and placebo were purchased from the same factory and coded by the third person who is not involved in the study. the patients were received the random code by the secretariat who is not involved in the study. the patients with even numbers will receive the capsules from box A and the patients with odd numbers will receive the capsules from box B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St. Tabriz University of Medical Sciences, Tabriz-Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.TBZMED.REC
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
Disease activity index (measured using mayo clinic score)
Timepoint
Before and after 2 month of intervention
Method of measurement
Clinical data
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25000 IU vitamin A per day for two months
Category
Treatment - Other
2
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza tabriz hospital
Full name of responsible person
Mohamadreza rohani
Street address
Golgasht street, imam Reza hospital-Tabriz University of medical sciences, Tabriz-Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 7473
Email
Mohamadreza.rohani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab nikniaz
Street address
Golgasht St, Imam Reza hospital, Tabriz University of medical aciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 7473
Email
znikniaz@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamadreza rohani
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Gasteroenterology and hepatology
Street address
Golgasht St. Imam Reza hospital, Tabriz University of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 7473
Email
Mohamadreza.rohani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kurosh masnadi
Position
Asistant proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gasteroenterology and hepatology
Street address
Golgasht St.,Imam Reza hospital, Tabriz University of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 7473
Email
kurmas23@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamadreza rohani
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
gastroenterology
Street address
Golghasht Street, Imam Reza hospital, Tabriz University of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41133367473
Email
Mohamadreza.rohani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
demographic characteristics: all data after deleting the name of patients
disease activity questionnaire: all data after deleting the name of patients
serum level of vitamin A: all data after deleting the name of patients
When the data will become available and for how long
4 months after initiation of the study
To whom data/document is available
research vice chancellor of Tabriz University of medical sciences
Under which criteria data/document could be used
data analysis can be done on all data
From where data/document is obtainable
Liver and gastrointestinal diseases research center, Tabriz University of medical sciences
What processes are involved for a request to access data/document
sending the requerst by email to Liver and gastrointestinal diseases research center, Tabriz University of medical sciences