Objective: evaluation the effect of atorvastatin in patients with ulcerative colitis. Design of the study: randomization using random permuted blocks, convenience sampling, double-blind, placebo-controlled, single-center, phase II trial. Study population: all patients in the age range of 18 to 60 years old with a definite pathological diagnosis of UC.
Main inclusion criteria: developing ulcerative colitis with pathologic confirmation; patients at the age of 18-60 years old.
Main exclusion criteria: not taking medication as directed by doctor; drug allergy or severe drug side effects; cancer; history of surgery on the gastrointestinal tract; malabsorption disease; vasculitis disease.
Sample size: 20.
Interventions: addition of 20 miligram atorvastatin/daily for 6 months to routine treatment regime including asacol, azathioprine and hydrocortisone in intervention group. In control group, patients will receive the same regime except they receive placebo instead of atorvastatin. Intervention time: after the diagnosis. Outcomes of interest: hospitalization rate, the need for steroids, frequency of flare, duration of remission.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102730528N1
Registration date:2017-01-01, 1395/10/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-01, 1395/10/12
Registrant information
Name
Leila Hosseini
Name of organization / entity
Zahedan Medical University of Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
dr.hosseini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ِComparison the effect of atorvastatin nd placebo on disease flare frequency in patients with ulcerative colitis: a randomized clinical trial
Public title
The effect of atorvastatin in the treatment of ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: developing ulcerative colitis with pathologic confirmation; patients at the age of 18-60 years old.
Main exclusion criteria: not taking medication as directed by doctor; drug allergy or severe drug side effects; cancer; history of surgery on the gastrointestinal tract; malabsorption disease; vasculitis disease.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization using random permuted blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2015-06-10, 1394/03/20
Ethics committee reference number
IR.ZAUMS.REC.1394.222
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
Duration of remission
Timepoint
Every 3 months since study start
Method of measurement
Day
2
Description
Frequency of flare
Timepoint
Every 3 months since study start
Method of measurement
Number
3
Description
The need for steroids
Timepoint
Every 3 months since study start
Method of measurement
Miligram per kilogram
4
Description
Number of hospitalization
Timepoint
Every 3 months since study start
Method of measurement
Number
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Addition of 20 miligram atorvastatin/daily for 6 months to routine treatment regime including asacol, azathioprine and hydrocortisone
Category
Treatment - Drugs
2
Description
Control group: Addition of 20 miligram plasebo/daily for 6 months to routine treatment regime including asacol, azathioprine and hydrocortisone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Leila Hosseini
Street address
Internal Medicine Department, Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Leila Hosseini
Position
Internal Medicine Residence
Other areas of specialty/work
Street address
Internal Medicine Department, Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Postal code
9816737789
Phone
+98 54 3329 5583
Fax
Email
Dr.hosseini@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Bakhshipour
Position
Associate Professor of Internal Medicine/ Fellowship of Gastrointestinal Disease
Other areas of specialty/work
Street address
Internal Medicine Department, Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Postal code
9816737789
Phone
+98 54 3329 5580
Fax
Email
Dr.bakhshipour@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Leila Hosseini
Position
Internal Medicine Diseases Residence
Other areas of specialty/work
Street address
Internal Medicine Department, Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Postal code
9816737789
Phone
+98 54 3329 5794
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)