Protocol summary

Summary
This randomized Placebo controlled clinical trial to evaluate the effect of supplementation "zinc" in the outcome of elderly patients hospitalized with community-acquired pneumonia will be done. 90 elderly patients hospitalized with community-acquired pneumonia at 92 and 93 years Boali and Velayat Qazvin Hospitals, will randomly assigned to two groups of capsules 110mg two times a 4-day zinc sulfate, and the group of placebo. All patients will receive standard antibiotic treatment for pneumonia. Groups will be compared the initial characteristics. Outcomes will be compared in two groups, the number of days of hospitalization, days with tachypnea, hours of fever, duration of hypoxia, and on the third-fifth day of systolic and diastolic blood pressure, improve the level of consciousness, resolution of leukocytosis, ESR, platelet count.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015013120882N1
Registration date: 2015-04-04, 1394/01/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-04, 1394/01/15
Registrant information
Name
Abbas Allami
Name of organization / entity
Qazvin University of Medical Scince
Country
Iran (Islamic Republic of)
Phone
+98 28 3337 9630
Email address
allami@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Zink supplement effect in Community Acquired Pneumonia Outcome in hospitalized Patients
Public title
Effect of Zink Sulphate in Pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Community Acquired Pneumonia; admitted patient; older than 50 years; Exclusion Criteria: Severe neurologic disease; Admission more than 25 days; Death due to Other Causes;
Age
From 50 years old to 100 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)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Research and technology Center, Qazvin University of Medical Sciences, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2013-10-14, 1392/07/22
Ethics committee reference number
28/20/7921

Health conditions studied

1

Description of health condition studied
Pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified

Primary outcomes

1

Description
Duration Of Admission
Timepoint
Day1, Day2, Day3, ... Day of discharge
Method of measurement
records

2

Description
Duration Of Tachypnea
Timepoint
Day1, Day2, Day3, ... Day of discharge
Method of measurement
Examination

3

Description
Duration Of Tachycardia
Timepoint
Day1, Day2, Day3, ... Day of discharge
Method of measurement
Examination

4

Description
Blood Pressure day 4
Timepoint
Time of Admission, 4th Day
Method of measurement
Barometer

5

Description
Duration Of Fever
Timepoint
Time of Admission, 6hours Later, 12hours Later, 18hours Later, Time of Discharge
Method of measurement
Thermometer

6

Description
Duration Of Hypoxia
Timepoint
Day1, Day2, Day3, ... Day of discharge
Method of measurement
Electronic Pulseoxymeter

7

Description
GCS Day 4
Timepoint
Time of Admission, 4th Day
Method of measurement
Examination

8

Description
WBC Day 4
Timepoint
Time of Admission, 4th Day
Method of measurement
Laboratory

9

Description
ESR Day 4
Timepoint
Time of Admission, 4th Day
Method of measurement
Laboratory

10

Description
Platelet Day 4
Timepoint
Time of Admission, 4th Day
Method of measurement
Laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Zinc Sulphate 110 mg Capsules q12h for 4 days
Category
Treatment - Drugs

2

Description
Control Group: Placebo Capsules Same as Zinc Sulphate 110 mg Capsules q12h for 4 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bouali Hospital
Full name of responsible person
Dr Saeed Sharafi
Street address
Infectious Disease Ward, Bouali Hospital
City
Qazvin

2

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Dr. Saeed Sharafi
Street address
Velayat Hospitsl, Taavon Sq. ,22 Bahaman Blvd, Elahieh
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Abbasi
Street address
Research and technology Center, Qazvin University of Medical Sciences, Shahid Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeed Sharafi
Position
Infectious Disease Resident
Other areas of specialty/work
Street address
Infectious Disease Ward, Bouali Hospital
City
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6032
Fax
+98 28 3333 7006
Email
saeedsharafi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Meddical Science
Full name of responsible person
Dr. Abbas Allami
Position
Infectious Disease Specialist
Other areas of specialty/work
Street address
Infectious Disease Ward, Bouali Hospital
City
Qazvin
Postal code
Phone
+98 28 3332 6032
Fax
+98 28 3333 7006
Email
allami9@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qavin University of Medical Sciences
Full name of responsible person
Dr. Saeed Sharafi
Position
Infectious Disease Resident
Other areas of specialty/work
Street address
Infectious Disease Ward, Bouali Hospital
City
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6032
Fax
Email
saeedsharafi@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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