Effect of zinc supplementation versus control group on cellular immunity, treatment, and relapse of brucellosis: a single-blind randomized clinical trial
To assess the effect of zinc supplementation versus control group on cellular immunity, treatment, and relapse of brucellosis
Design
This is a single-blind randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with acute brucellosis referring to the Sina Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single-blinded so that patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 15 to 60 years,
Acute brucellosis
Exclusion criteria:
Pregnancy,
History of brucellosis,
Complicated brucellosis,
Chronic diseases such as cardiovascular disease, anemia, bone carcinoma,
Concurrent with AIDS,
A history of collagen vascular disease,
History of zinc use
Intervention groups
Intervention group:
Routine treatment brucellosis plus Zinc gluconate tablet (manufactured by Darukadeh Pharmaceutical Co.) 30 mg daily for 8 weeks
Control group:
Routine treatment brucellosis
Main outcome variables
Primary outcome:
Clinical symptoms, treatment of the disease, relapse of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N332
Registration date:2020-01-11, 1398/10/21
Registration timing:prospective
Last update:2020-01-11, 1398/10/21
Update count:0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation versus control group on cellular immunity, treatment, and relapse of brucellosis: a single-blind randomized clinical trial
Public title
Effect of zinc supplementation versus control group on cellular immunity, treatment and relapse of brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 to 60 years,
Acute brucellosis
Exclusion criteria:
Pregnancy,
History of brucellosis,
Complicated brucellosis,
Chronic diseases such as cardiovascular disease, anemia, bone carcinoma,
Concurrent with AIDS,
A history of collagen vascular disease,
A history of zinc use
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drugs will be given in coded envelopes. Therefore, patients will be unaware of the type of intervention. Thus, the trial will be run as single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.UMSHA.REC.1398.767
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Clinical symptoms
Timepoint
Before the intervention and 1 and 2 months later
Method of measurement
By taking history and physical examination
2
Description
Treatment of the disease
Timepoint
1 and 2 months after the intervention
Method of measurement
by using 2ME test
3
Description
Relapse of the disease
Timepoint
6 months after the intervention
Method of measurement
by using 2ME test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment brucellosis plus Zinc gluconate tablet (manufactured by Darukadeh Pharmaciutical Co.) 30 mg daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Routine treatment brucellosis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr. Fariba Keramat
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
faribakeramat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Fariba Keramat
Position
Specialist in Infectious Diseases
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
faribakeramat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Fariba Keramat
Position
Specialist in Infectious Diseases
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
faribakeramat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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