This study compares the effect of vitamin D in improvement of patients with pneumonia . This study is a double blind randomized clinical trial. The study included all patients with pneumonia (based on clinical and radiological diagnosis of pneumonia) hospitalized in Kashan Shahid Beheshti hospital. The exclusion criteria consist of malnutrition and systemic disease. Patients were randomly divided into two groups of 60 cases that the intervention group received oral vitamin D3 2000 IU with antibiotics (standard treatment for pneumonia based on clinical findings and the opinion of infectious disease specialist) for 7 days. The control group received antibiotics (standard treatment for pneumonia) and placebo for 7 days. Then improvement of clinical symptoms, hemodynamics and length of hospitalization were evaluated and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511023576N3
Registration date:2017-04-18, 1396/01/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-18, 1396/01/29
Registrant information
Name
Zahra Soleimani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0030
Email address
soleimani.zahra@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin D on the course of pneumonia in patients admitted of Shahid Beheshti Hospital in 2014-2015
Public title
vitamin D on the course of pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical and radiological diagnosis of pneumonia; aged more than 18 years; consent to the entry into the study; able to eat oral vitamin D and placebo. The exclusion criteria: malnutrition; systemic disease; diarrhea; intolerance or sensitivity to vitamin D; recent use of antibiotics.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2014-12-17, 1393/09/26
Ethics committee reference number
4914
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J09, J10,
ICD-10 code description
Influenza and pneumonia
Primary outcomes
1
Description
Clinical signs
Timepoint
At admission, 48 hours after taking the drug, 96 hours after taking the drug, at discharge
Method of measurement
Physical examination
Secondary outcomes
1
Description
Length of stay in hospital
Timepoint
At discharge
Method of measurement
Review patient records
2
Description
Hemodynamic
Timepoint
At admission 48 hours after taking the drug, 96 hours after taking the drug, at discharge
Method of measurement
Barometer, thermometer, examination
3
Description
Duration of stoping cough and shortness of breath
Timepoint
At admission 48 hours after taking the drug, 96 hours after taking the drug, at discharge
Method of measurement
Question from patient
Intervention groups
1
Description
The intervention group: start the standard antibiotic treatment for pneumonia and received 1000 units of vitamin D daily for 7 days from the second day after the entry into the study
Category
Treatment - Drugs
2
Description
Control group: Starting the standard antibiotic treatment for pneumonia and received placebo tablets with the same shape and size from the second day after entry into the study