The aim of this clinical trial is to evaluate the effect of zinc supplement on the pulmonary tuberculosis patients’ outcome.
Design: A double blind clinical trial will be conducted. 90 smear positive pulmonary tuberculosis patients size will be included. Samples will be collected from referred patients to Hospital and three Sistan tuberculosis centers.
Methods: The smear positive patients’ blood will be collected for zinc level evaluation. Moreover their chest-X-Ray image will be collected. The patients will be divided randomly into two groups of Intervention (A) and control (B). The group A subjects (n=45) will be treated by 10cc of 0.5% zinc syrup (with standard module) once a day and in group B (n=45) will be received placebo syrup with same prescription. The blood zinc level and sputum smear will be evaluated again in the end of second, fourth and sixth months and smear changes and changes in serum zinc will be compared and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110630729N1
Registration date:2016-12-26, 1395/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Donya Arefi
Name of organization / entity
Zabol University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 0768
Email address
donya.arefi@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Zabol University of Medical Sciences Deputy of Research and Technology
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Zinc as a supplemental therapy in the treatment of patients with pulmonary tuberculosis
Public title
Effects of Zinc in the treatment of patients with pulmonary tuberculosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All tuberculosis diagnosed patients with the age ranged between 10-60 years. Exclusion criteria: Any chromosomal disorders; allergy to zinc; chronic renal disease; any other supplement or placebo assumption; side effect appearance such as blurred vision, pulmonary edema, icter and severe gastrointestinal symptoms.
Age
From 10 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Zabol University of Medical Sciences and Health Services
Street address
Zabol University of Medical Sciences, Shahid Rajai Street, Zabol, Sistan and Baluchestan
City
Zabol
Postal code
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
zbmu.1.REC.1395.64
Health conditions studied
1
Description of health condition studied
Pulmonary tuberculosis
ICD-10 code
A15
ICD-10 code description
Respiratory tuberculosis, bacteriologically and histologically confirmed
Primary outcomes
1
Description
Sputum smear
Timepoint
Beginning of diagnosis and two months, four months and six months after diagnosis
Method of measurement
Sputum smear
Secondary outcomes
1
Description
Serum zinc level
Timepoint
Beginning of diagnosis and two months, four months and six months after diagnosis
Method of measurement
Serum zinc level in micrograms per liter
Intervention groups
1
Description
Treatment intervention will be conducted by using zinc sulfate syrup (250 mg dosage) (Iran Daroo company) which will be taken once a day (after dinner) for six months
Category
Treatment - Drugs
2
Description
and intervention with placebo will be conducted with placebo assumption once a day (after dinner) for six months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Zahra Sepehri
Street address
Zabol-Zahedan highway، Rustam square
City
Zabol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences and Health Services
Full name of responsible person
Zahra Sepehri
Street address
Shahid Rajai Street , University of Medical Sciences
City
Zabol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences and Health Services
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
Zabol University of Medical Sciences
Full name of responsible person
Donya Arefi
Position
PhD/researcher
Other areas of specialty/work
Street address
Zabol University of Medical Sciences, Shahid Rajai Street,
City
Zabol
Postal code
Phone
+98 54 3223 0770
Fax
Email
donya.arefi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences/Vice-Chancellor for Research and Technology
Full name of responsible person
Zahra Sepehri
Position
Internal Medicine
Other areas of specialty/work
Street address
Zabol University of Medical Sciences, Shahid Rajai Street,
City
Zabol
Postal code
Phone
+98 54 3223 0770
Fax
Email
sepehri_za@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Donya Arefi
Position
PhD/researcher
Other areas of specialty/work
Street address
Zabol University of Medical Sciences, Shahid Rajai Street,
City
Zabol
Postal code
Phone
+98 54 3223 0770
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)