The rate of relapse are determined in the intervention and control group.
Design
Double blind randomized clinical trial with control group.
Randomization will be performed based on random numbers.
The sample size will be 110 patients in both intervention and control groups.
This study will be conducted in the third phase of clinical trial.
Settings and conduct
The study will be conducted at ValiAsr Hospital in Arak.
The study will also be doubleblind, and the participating patients and the statistical analyst will be blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients who have positive serologic tests for Brucella.
Exclusion criteria:
All patientsl with focal complications of Brucellosis include Brucella spondylitis, Brucella endocarditis, and Neurobuccosis.
All patients who have any immune deficiency.
Intervention groups
Patients in the control group will receive usual treatment (rifampin 600 mg once daily for 6 weeks and doxycycline with a dose of 100 mg twice daily for 6 weeks) for brucellosis also they will receive placebo daily for 6 weeks.
Patients in the intervention group, in addition to receiving the usual treatment for brucellosis, will receive vitamin with a dose of 25,000 units daily for 6 weeks.
Main outcome variables
Relapse.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180815040807N1
Registration date:2018-10-28, 1397/08/06
Registration timing:registered_while_recruiting
Last update:2018-10-28, 1397/08/06
Update count:0
Registration date
2018-10-28, 1397/08/06
Registrant information
Name
nooshin Ahmadvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
n.ahmadvand@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-03, 1397/04/12
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin A adjuvant therapy on the decrease of relapse of Brucellosis.
Public title
Evaluation of the vitamin A on the treatment of Brucellosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have positive serologic tests for Brucella.
Exclusion criteria:
All patients with focal complications of Brucellosis include Brucella spondylitis, Brucella endocarditis, and Neurobuccosis.
All patients who have any immune deficiency.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple randomization way by using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
To perform the blindness of this study, Patients and statistical analyzers of will be blind from the type of group and receiving vitamin A or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Basij Blv.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.ARAKMU.REC.1397.106
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Relapse
Timepoint
Before the intervention, 1, 3, 6, 12 and 15 months after the intervention.
Method of measurement
Patients will be evaluated for the disease recurrence by measuring antibody titres against brucellosis.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group, in addition to receiving the usual treatment for brucellosis, will receive vitamin with a dose of 25,000 units daily for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will receive usual treatment (rifampin 600 mg once daily for 6 weeks and doxycycline with a dose of 100 mg twice daily for 6 weeks) for brucellosis also they will receive placebo daily for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valias hospital, arak, Iran.
Full name of responsible person
Noushin ahmadvand
Street address
Emam Khomeini Blvd.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
n.ahmadvand@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad arjmandzadegan
Street address
Basij blvd
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Noushin ahmadvand
Position
Resident of infection disease.
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Emam Khomeini Blvd
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
n.ahmadvand@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nooshin Ahmadvand
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Valiasr Hospital
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3222 2003
Fax
Email
n.ahmadvand@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nooshin Ahmadvand
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Valiasr Hospital
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3222 2003
Fax
Email
n.ahmadvand@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Secrecy of patient information
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