Determining the effect of oral vitamin C on liver toxicity and increasing the clinical effectiveness of anti-TB drugs
Design
A randomized, blinded clinical trial with control group,
Settings and conduct
The researcher, referring to the health centers, randomly placed the patients with positive tuberculosis in one of the three groups and the first tests were requested and one-month intervals of the tests are repeated two times. From the beginning of the study, for two months every two weeks Phone calls for hepatotoxic symptoms
Participants/Inclusion and exclusion criteria
Patients with newly diagnosed positive smear-positive pulmonary tuberculosis with a minimum age and from any race if they are satisfied with participation in the study without a history of liver disease, they started studying
Intervention groups
Three groups of 30 people are present in the study: 1.Control group receives placebo tablet once per day 2.The group receives 500 mg vitamin C per day 3.The group receives 1000 mg vitamin C per day Patients receive their anti-tuberculosis drugs in the usual way
Main outcome variables
Reduce the symptoms and impairment of liver tests in taking vitamin C
General information
Reason for update
Acronym
Interventional
IRCT registration information
IRCT registration number:IRCT20170904036060N2
Registration date:2018-05-30, 1397/03/09
Registration timing:retrospective
Last update:2018-05-30, 1397/03/09
Update count:0
Registration date
2018-05-30, 1397/03/09
Registrant information
Name
naser vahdati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8818
Email address
vahdatin@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Approved Budget Plans at Mashhad University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of vitamin C on reducing anti-Tuberculous hepatotoxicity
Public title
protective effect of vitamin C on hepatotoxicity of anti-Tuberculous drugs
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pulmonary and non pulmonary tuberculosis documented by sputum acid-fast smear, pathologic confirmation
willingness to participate in the study
Exclusion criteria:
sign of acute or chronic liver disease according to history, physical examination and preliminary lab data
Age
From 18 years old to 99 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, responsible for filling out questionnaires and collecting data, health authorities at the centers were blinded to the three groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Imam Reza Hospital, Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
38411538-051
Approval date
2015-11-07, 1394/08/16
Ethics committee reference number
IR.MUMS.REC.1394.485
Health conditions studied
1
Description of health condition studied
Protective effect of vitamin C on hepatotoxicity of tuberculosis drugs
ICD-10 code
A15.0
ICD-10 code description
Tuberculosis of lung
Primary outcomes
1
Description
Disorders of the liver enzymes
Timepoint
Measure liver enzymes before the onset of intervention, one month after the start and two months after the start
Method of measurement
Examination of blood samples
Secondary outcomes
1
Description
Clinical symptoms and signs of hepatic toxicity
Timepoint
The beginning of the study. A month later. Two months later
Method of measurement
Liver test
2
Description
Sperm smear negative for TB
Timepoint
Second month
Method of measurement
Sample sputum examination for tuberculosis
Intervention groups
1
Description
First intervention group: Receiving 500 milligrams of vitamin C per day for two months
Category
Treatment - Other
2
Description
Intervention group2:: Receiving one gram of vitamin C per day for two months
Category
Treatment - Other
3
Description
Control group: Receives a placebo tablet (similar to vitamin C tablets) daily for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Mashhad
Full name of responsible person
Mahnaz Amini
Street address
Imam Reza Hospital. Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
3845 6179
Email
aminim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Vahdati Mashhadiyan
Street address
Azadi Square. Pharmaceutical Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
136591775
Email
Vahdatin@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahnaz Amini
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Bahar street.Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
00
Fax
Email
aminim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Nasser Vahdati Mashhadian
Position
PhD of toxicology from the University of Guildford,UK
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences.Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177513651
Phone
00
Fax
Email
Vahdatin@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elnaz Samadi
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza hospital.Imam Reza Square. Spring Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177765661
Phone
00
Fax
Email
samadise931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available