Evaluation of efficacy of atorvastatin on calprotectin in patients with ulcerative colitis.
Design
40 patients will randomly divided into intervention and control groups. 20 patient will participate in each group. the study will be performed as a phase 2 double-blind, placebo-controlled clinical trial.
random sequence was obtained using the online software available on the www.sealedenvelope.com website.
Settings and conduct
In this study patients with ulcerative colitis in GI clinic of BouAli hospital in Tehran,Iran who met inclusion criteria will randomly divided in two groups of placebo and treatment. each group consist of twenty patients. all patients will receive standard treatments.
Treatment group will receive 40mg Atorvastatin once daily and placebo group will receive placebo tablets once daily.
At the beginning of study and day 60 quality of life questionnaire, and disease severity questionnaire, blood samples for assessment of CRP and ESR, and stool samples for the analysis of Stool Calprotectin will be taken.
Drug and placebo will be filled in identical containers by a third person, each container will have a unique code.
The researcher, physician and patients are not aware of the allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ulcerative colitis patients in the remission phase, age between 18-65 years old
Exclusion criteria: patients under 18 and over 65 years old, sensitivity to statins and pregnant and lactating women.
Intervention groups
Intervention group: patients will receive one atorvastatin 40mg tablet daily for 6 months.
Control group: patients will receive one placebo tablet daily for 6 months.
Main outcome variables
Calprotectin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210713051878N1
Registration date:2022-09-08, 1401/06/17
Registration timing:retrospective
Last update:2022-09-08, 1401/06/17
Update count:0
Registration date
2022-09-08, 1401/06/17
Registrant information
Name
Babak Baniadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3669 9468
Email address
babakba1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-22, 1400/05/31
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of atorvastatin effect on disease severity and quality of life in ulcerative colitis patients.
Public title
Atorvastatin effect on ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in remission phase of ulcerative colitis
Age of between 18-65
Informed Consent
Exclusion criteria:
Pregnancy
Lactation
History of statin sensitivity
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
3
Stool calprotectin, ESR ,CRP, and questionnaire are obtained at the start of the study, after two month, and at the end of the study.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on block randomization in blocks of four,
This list is built up by an online software available at www.random.org website.
Patients were divided in two groups of twenty patients based on blocks of four.
One group of twenty patients will receive treatment and the other group will receive placebo.
The researcher is not aware about patients allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug and placebo are filled by a third person in same packs and coding's are included by two numbers and two letters ( unique codes assigned for each packs).
Researcher is blinded about these codes up to end of the search.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Medical sciences.
Street address
Yakhchal street, Shariati street,Tehran town.
City
Tehran
Province
Tehran
Postal code
4563490102
Approval date
2020-12-20, 1399/09/30
Ethics committee reference number
IR.IAU.PS.REC.1399.275
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51.9
ICD-10 code description
Ulcerative colitis, unspecified
Primary outcomes
1
Description
Calprotectin detection by Radio immune assay
Timepoint
Measurement of Calprotectin at the beginning of the study and after 2 months.
Method of measurement
Stool calprotectin measurement by Radio immune assay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 patients of ulcerative colitis who refer to gastrointestinal department of Bouali hopital (Tehran-Iran) will receive atorvastatin 40mg (Sobhan Darou-Rasht-Iran) in similar packs and will take them once daily oral used for 2 months.
Category
Treatment - Drugs
2
Description
Control group: 20 patients of ulcerative colitis who refer to gastrointestinal department of Bouali hopital (Tehran-Iran) will receive placebo tablets that made in Tehran medical science Islamic Azad University in similar packs and will take them once daily oral used for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology clinic of Bu Ali hospital Tehran
Full name of responsible person
Babak Bani Adam
Street address
yakhchal ave,Shariati Srteet,Tehran Town.
City
Tehran
Province
Tehran
Postal code
4561245671
Phone
+98 21 2257 8947
Email
babakba1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Yakhchal ave., Shariati street., Tehran town
City
Tehran
Province
Tehran
Postal code
1545757890
Phone
+98 21 2245 6877
Email
babakba1374@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
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
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal ave.,Shariati street Tehran Town
City
Tehran
Province
Tehran
Postal code
1245789630
Phone
+98 21 4228 7965
Email
babakba1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Javad Rastegar Moghaddam
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Yakhchal ave.,Shariati street., Tehran Town
City
Tehran
Province
Tehran
Postal code
5352875320
Phone
+98 21 2254 8796
Email
babakba1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Babak Bani Adam
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal ave., Shariati Street., Tehran Town
City
Tehran
Province
Tehran
Postal code
1245789652
Phone
+98 21 2248 7856
Email
babakba1374@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available