The objective of this randomized double blind trial is to investigate the effect of Zinc supplementation on the recovery and reduce the symptoms of tuberculosis .
100 newly patients with pulmonary tuberculosis after filling the informed consent forms and questionnaires are randomly divided into two groups .
The patients in the intervention group will receive 30 mg zinc every 48 h for 6 months with TB drugs but the control group will receive placebo every 48 h with TB drugs.Clinical manifestations (Smear,chest radiography ) ,BMI and serum level of zinc ,copper ,iron ,urea,creatinine albumin, total protein,alkaline phosphatase ,SGOT,SGPT will take place in patients at the baseline ,2 month and 6 month and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112178429N1
Registration date:2012-08-09, 1391/05/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Fatemeh Pourfallah
Name of organization / entity
Institute Pasteur of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 2770
Email address
fpourfallah@pasteur.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute Pasteur of Iran
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation in improving pulmonary tuberculosis patients in Qom
Public title
Effect of zinc supplementation on tuberculosis therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria includes having tuberculosis and filling the informed consent
Exclusion criteria includes getting diseases such as cancer, stroke, immiunosupprision diseases and not taking mineral supplement or placebo
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Instiute Pasteur of Iran
Street address
Pasteur Sq
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
3020/0201/90
Health conditions studied
1
Description of health condition studied
Pulmonary tuberculosis
ICD-10 code
A15-A19
ICD-10 code description
infections due to Mycobacterium tuberculosis and Mycobacterium bovis
Primary outcomes
1
Description
Stop fever
Timepoint
At the baseline ,2 month and 6 month later
Method of measurement
Physical exam
2
Description
Radiological signs
Timepoint
At the baseline ,2 month and 6 month later
Method of measurement
Chest radiology
3
Description
Smear negative
Timepoint
At the baseline ,2 month and 6 month later
Method of measurement
Smear
4
Description
Stop coughing
Timepoint
At the baseline ,2 month and 6 month later
Method of measurement
Physical exam
Secondary outcomes
1
Description
Serum Zinc
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
Atomic Absorption
2
Description
Serum Copper
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
Atomic Absorption
3
Description
Serum Fe
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
RA 1000
4
Description
Serum ALK
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
RA 1000
5
Description
Serum Albumin
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
RA 1000
6
Description
Body Mass Index
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
weight(kg)/height2 (m2)
7
Description
Serum SGPT
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
RA 1000
8
Description
Serum SGOT
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
RA 1000
9
Description
Serum total protein
Timepoint
At baseline ,2 month and 6 month later
Method of measurement
RA 1000
Intervention groups
1
Description
Dietary Zinc supplement ,30 mg( zinc) every 48 h for 6 month
Category
Treatment - Drugs
2
Description
Placebo every 48 h for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center of Qom
Full name of responsible person
Dr Bahareh Zare
Street address
Emam Ave.
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Institute Pasteur of Iran
Full name of responsible person
Dr Saeed Bozari
Street address
Pasteur Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute Pasteur of Iran
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
Institute Pasteur of Iran
Full name of responsible person
Dr Fatemeh Pourfallah
Position
Faculty member/ DVM, MPH
Other areas of specialty/work
Street address
Pasteur Ave.
City
Tehran
Postal code
1316943551
Phone
+98 21 6640 2770
Fax
Email
fpourfallah@pasteur.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute Pasteur
Full name of responsible person
Dr Fatemeh Pourfallah
Position
DVM, MPH
Other areas of specialty/work
Street address
Pasteur Ave.
City
Tehran
Postal code
1316943551
Phone
+98 21 6640 2770
Fax
Email
fpourfallah@pasteur.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Institute Pasteur of Iran
Full name of responsible person
Dr Fatemeh Pourfallah
Position
Faculty member/ DVM, MPH
Other areas of specialty/work
Street address
Pasteur Ave.
City
Tehran
Postal code
1316943551
Phone
+98 21 6640 2770
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)