Aim: Evaluation of vitamin B6 efficacy in clinical and laboratory manifestation of patients with ulcerative colitis. Study design: randomized, double blind, controlled with placebo, uni-center, phase 2 trial. Inclusion criteria: patients with ulcerative colitis confirmed by clinical diagnosis, pathology, and previous results of colonoscopy; before this, have not used from vitamin B6 and other vitamin B derivatives for ulcerative colitis; patients in any stage and with any intensity are candidate for participating in the study.
Exclusion criteria: persons with parkinsonism that use Levodopa, simultaneously (because of interfere with vitamin B6 and Levodopa); patient unwillingness for continue to study. Sample size: intervention group: 30 persons, and control group: 30 persons. Interventions studied: designed in two groups: group 1: patients with ulcerative colitis (n=30) that receive routine treatment with placebo (40 mg/day), and group 2: patients with ulcerative colitis (n=30) that receive routine treatment with vitamin B6 (40 mg/day). Duration of intervention: 6 months. Initial consequences: intensity rate of clinical signs such as number of daily defecation and admission times, the dosage of Mesalazine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017063034820N1
Registration date:2017-08-29, 1396/06/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-29, 1396/06/07
Registrant information
Name
Fateme Panahande
Name of organization / entity
Ahvaz Jundishapour University of medical sciences
Country
Iran (Islamic Republic of)
Phone
-
Email address
panahande.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin B6 efficacy in clinical and laboratory manifestation of patients with Ulcerative colitis
Public title
Effect of vitamin B6 on treatment of ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with ulcerative colitis confirmed by clinical diagnosis, pathology, and previous results of colonoscopy; before this, have not used from vitamin B6 and other vitamin B derivatives for ulcerative colitis; patients in any stage and with any intensity are candidate for participating in the study.
Exclusion criteria: persons with parkinsonism that use Levodopa, simultaneously (because of interfere with vitamin B6 and Levodopa); patient unwillingness for continue to study.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ahwaz Jundishapour University of Medical Sciences
Street address
Ahwaz Jundishapour University of Medical Sciences
City
Ahwaz
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.AJUMS.REC.1395.821
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
daily defecation
Timepoint
duration of the study
Method of measurement
times
2
Description
admission
Timepoint
0 & 6th months of the study
Method of measurement
times
3
Description
Mesalazine drug
Timepoint
0 & 6th months of the study
Method of measurement
dosage
Secondary outcomes
1
Description
ESR
Timepoint
0 & 6 months of the study
Method of measurement
Blood test
2
Description
CRP
Timepoint
0 & 6 months of the study
Method of measurement
Blood test
3
Description
plasma homocysteine
Timepoint
0 & 6 months of the study
Method of measurement
Blood test
4
Description
stooll Calprotectin
Timepoint
0 & 6 months of the study
Method of measurement
stool exam
Intervention groups
1
Description
Control group: patients with ulcerative colitis (number=30) that receive routine treatment with placebo (40 mg/day).
Category
Placebo
2
Description
Intervention group: patients with ulcerative colitis (number=30) that receive routine treatment with vitamin B6 (40 mg/day).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital, Ahwaz Jundishapour University of medical sciences
Full name of responsible person
Pezhman Alavinejad
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Mr. Dianat
Street address
Ahwaz Jundishapour University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapour 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
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Fateme Panahande
Position
Medical student
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Ahwaz
Postal code
Phone
+98 916 674 1582
Fax
Email
Fateme.b.dr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Pezhman Alavinejad
Position
Assistant professor of gastroentrology and hepatology
Other areas of specialty/work
Street address
No. 16, 16 Street, Kianpars
City
Ahwaz
Postal code
Phone
+98 61 3292 1839
Fax
Email
Pezhmanalavinejad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Seied Ali Mard
Position
Physiologist, phd
Other areas of specialty/work
Street address
Ahwaz Jundishapour University of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 3292 1839
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)