Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia

Pneumonia Clinical Trial

Official title:

The Effects of Vitamin D Supplementation in Respiratory Index of Severity in Children (RISC) of Hospitalized Patients With Community-acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936895
• Other study ID #: 188
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2016
• Last updated: October 14, 2016
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Vitamin D3
vitamin D at a dose of 50,000 IU per day for 2 days
• Placebo
Placebo for 2 days

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Mohammadi hospital	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	through study completion, an average of 4 days	No
Secondary	Duration of hospitalization	Duration of hospitalization of the patient	through study completion, an average of 4 days	No