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Assess the effectiveness of vitamin D in the treatment of pulmonary tuberculosis

Protocol summary

Summary
After adjusting for age and gender in this study, 64 patients were randomly divided into two groups. Written consent from all patients before participation in the study will be taken. The trial group, along with the standard 6-month TB treatment, vitamin D (450000 units IM in a single dose therapy) received, and to Controls, along with standard treatment for TB placebo is given. A clinical evaluation of all patients before the plan is adopted Including chest radiography, measurements of height, weight, blood samples (to measure levels of vitamin D, CBC, ESR, and CRP) . Patients on days 14, 28, 42 and 56 after treatment by medical examination will be followed up. At each follow-up sputum from patients and blood samples are taken and measured their weight and blood parameters. The SF-12 questionnaire to assess the health of older adults treated by Persian standards used at the beginning and end of the second month of treatment, the treatment is completed.

General information

Acronym
Adjuvant therapy
IRCT registration information
IRCT registration number: IRCT201407029855N5
Registration date: 2014-07-25, 1393/05/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-25, 1393/05/03
Registrant information
Name
Aiasghar Farazi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 6526
Email address
dr.farazi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assess the effectiveness of vitamin D in the treatment of pulmonary tuberculosis
Public title
Adjuvant treatment with vitamin D in tuberculosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with smear positive pulmonary tuberculosis; younger than 15 years for entry into the study; obtain informed consent Exclusion criteria: Patients who have medical complications during the follow-up study; patients who need to change during the study medication are routine tuberculosis; Patients who are suffering from systemic disease or other debilitating (Such as chronic liver disease, kidney disease, HIV, Malignancy etc); patients who have recently used of vitamin D in any other reason; Patients taking vitamin D in the past have suffered side effects or drug allergy; Pregnancy; in patients who taking of vitamin D is prohibited
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
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
Arak University of Medical Sciences
Street address
School of Medicine, Sardasht, Arak
City
Arak
Postal code
Approval date
2014-03-16, 1392/12/25
Ethics committee reference number
92-157-8

Health conditions studied

1

Description of health condition studied
Tuberculosis
ICD-10 code
A-15.o
ICD-10 code description
Tuberculosis of lung,confirmed by sputum microscopy with or without culture

Primary outcomes

1

Description
Erythrocyte Sedimentation Rate
Timepoint
Weeks of 2,4,6,8
Method of measurement
With westergren method - millimeters per first hour

2

Description
C-Reactive Protein
Timepoint
Weeks of 2,4,6,8
Method of measurement
Latex method - 1+ to 4+

3

Description
Complete Blood Count
Timepoint
Weeks of 2,4,6,8
Method of measurement
Measurment of Hgb and WBC

4

Description
Improvement of patient's symptoms
Timepoint
Weeks of 2,4,6,8
Method of measurement
Check list

Secondary outcomes

1

Description
Improved quality of life
Timepoint
Day 0 and day 30 of treatment
Method of measurement
SF-12 questionnaire

Intervention groups

1

Description
In this clinical trial study, in 32 patients as case group, along with routine anti-tuberculosis treatment for 6 months, vitamin D 450,000 IU intramuscularly in a single dose at the beginning of treatment will be given.
Category
Treatment - Drugs

2

Description
In this clinical trial study, in 32 patients as control group, along with routine anti-tuberculosis treatment for 6 months, placebo (Normal Saline) intramuscularly in a single dose at the beginning of treatment will be given.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Aliasghar Farazi
Street address
Department of infectious diseases, Valiasr Hospital, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpoo
Street address
School of Medicine, Sardasht, Arak
City
Arak
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
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
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Infectious Diseases, Valiasr hospital, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
farazialiasghar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Infectious Diseases, Valiasr Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
farazialiasghar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Infectious Diseases, Valiasr Hospital, Arak Arak Markazi Iran, Islamic Republic Of
City
Postal code
Phone
+98 86 3224 1411
Fax
Email
farazialiasghar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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