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

NCT02936895 | Completed Phase 4 DMC

• 1 other identifier: 188
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Duration of hospitalization

  through study completion, an average of 4 days

Study Arms (2)

Vitamin D3 (Low dose)

EXPERIMENTAL

vitamin D at a dose of 50,000 IU per day for 2 days

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo (same size and shape) for 2 days

Drug: Placebo

Interventions

Vitamin D3 DRUG

vitamin D at a dose of 50,000 IU per day for 2 days

Also known as: cholecalciferol

Vitamin D3 (Low dose)

Placebo DRUG

Placebo for 2 days

Placebo

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 2 months to 6 years
• Definite diagnosis of pneumonia

You may not qualify if:

• 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

Sponsors & Collaborators

• Hormozgan University of Medical Sciences: lead

Study Sites (1)

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 18, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)