Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia
Primary Purpose
Pneumonia
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia
Eligibility Criteria
Inclusion criteria
- Aged between 2 months to 6 years
- Definite diagnosis of pneumonia
Exclusion criteria
- Immunocompromised patients
- Airway hypersensitivity or asthma
- allergies
- nasal polyps
- Using inhaled medications to one month prior to the study
- Receiving high doses of vitamin D
- Avoiding to complete informed consent form
Sites / Locations
- Shahid Mohammadi hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D3 (Low dose)
Placebo
Arm Description
vitamin D at a dose of 50,000 IU per day for 2 days
Placebo (same size and shape) for 2 days
Outcomes
Primary Outcome Measures
Respiratory Index of Severity in Children (RISC)
For determining severity of pneumonia, RISC (Respiratory Index of Severity in Children) scoring system was used, including oxygen saturation, chest retraction, wheezing and refusal to feed, and also contains standards growth (weight for age).
Secondary Outcome Measures
Duration of hospitalization
Duration of hospitalization of the patient
Full Information
NCT ID
NCT02936895
First Posted
October 12, 2016
Last Updated
October 14, 2016
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02936895
Brief Title
Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia
Official Title
The Effects of Vitamin D Supplementation in Respiratory Index of Severity in Children (RISC) of Hospitalized Patients With Community-acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children under 5 years. This rate was 2% in 2007.
Some studies have shown that supplementing with vitamin D reduces disease of the respiratory tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell lines. Studies about the role of vitamin D supplementation in pneumonia in children are inadequate to conclude about its role.
The aim of this study is to determine the efficacy of vitamin D supplementation in Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of hospitalized patients with community-acquired pneumonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 (Low dose)
Arm Type
Experimental
Arm Description
vitamin D at a dose of 50,000 IU per day for 2 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (same size and shape) for 2 days
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
vitamin D at a dose of 50,000 IU per day for 2 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 2 days
Primary Outcome Measure Information:
Title
Respiratory Index of Severity in Children (RISC)
Description
For determining severity of pneumonia, RISC (Respiratory Index of Severity in Children) scoring system was used, including oxygen saturation, chest retraction, wheezing and refusal to feed, and also contains standards growth (weight for age).
Time Frame
through study completion, an average of 4 days
Secondary Outcome Measure Information:
Title
Duration of hospitalization
Description
Duration of hospitalization of the patient
Time Frame
through study completion, an average of 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Aged between 2 months to 6 years
Definite diagnosis of pneumonia
Exclusion criteria
Immunocompromised patients
Airway hypersensitivity or asthma
allergies
nasal polyps
Using inhaled medications to one month prior to the study
Receiving high doses of vitamin D
Avoiding to complete informed consent form
Facility Information:
Facility Name
Shahid Mohammadi hospital
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79176
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia
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