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

Hormozgan University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Pneumonia

Treatments: Drug: Vitamin D3; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02936895

188

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 2 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Vitamin D3 (Low dose)

Experimental group

Description:

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

Treatment:

Drug: Vitamin D3

Placebo

Placebo Comparator group

Description:

Placebo (same size and shape) for 2 days

Treatment:

Drug: Placebo