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NCT Number: NCT02936895

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

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

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

Other names: cholecalciferol

Placebo

Drug

Placebo for 2 days

Primary outcomes

  1. Respiratory Index of Severity in Children (RISC)

    Time frame: through study completion, an average of 4 days

    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 outcomes

  1. Duration of hospitalization

    Time frame: through study completion, an average of 4 days

    Duration of hospitalization of the patient

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2016
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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