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

NCT ID: NCT02936895

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D3 (Low dose)

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

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

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

Placebo

Placebo (same size and shape) for 2 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 2 days

Interventions

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Vitamin D3

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

Intervention Type DRUG

Placebo

Placebo for 2 days

Intervention Type DRUG

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Mahboobi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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188

Identifier Type: -

Identifier Source: org_study_id

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