NCT02054182

Effect of Vitamin D Supplementation in Young South African Children Hospitalized With Acute Lower Respiratory Infection

Effect of Vitamin D Supplementation in Young Children With Acute Lower Respiratory Tract Infection at Dr George Mukhari Academic Hospital, Pretoria, South Africa

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: University of Limpopo · Academic / Other
• Sex: All
• Age: 1 Month – 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether vitamin D supplements given to children aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will improve symptoms and reduce the duration of hospitalization.

Detailed description

In a randomized, double blind placebo controlled interventional study, children aged 1 month to 5 years, who are admitted with acute lower respiratory tract infection (ALRTI) to Dr George Mukhari Academic Hospital will be enrolled. The children will randomized to receive 2500 IU of vitamin D or a placebo. It is intended to enrol 320 children, 160 to receive vitamin D and the other 160 to receive a placebo. This sample size was calculated at 80% power and 5% significance. The children will be enrolled within 24 hours of admission and the intervention (supplement or placebo) will be daily until the child is discharged fron the hospital. The severity of ALRTI will be assessed using the modified Respiratory Distress Assessment Instrument (MRDAI) score. The thorough physical examination and classification of severity of the symptoms will be done at enrolment and daily until hospital discharge. Blood samples for vitamin D and calcium concentrations will be assessed at enrolment, before the child is given the supplement or placebo. The difference in the improvement in MRDAI score between the placebo and the supplement will be assessed by analysis of variance (ANOVA). Similarly the difference in duration of hospital stay between the two groups will also be analysed using ANOVA. The association between the vitamin D levels and the MRDAI score on admission will also be assessed and analysed using ANOVA. All eligible children will be sequentially enrolled until the desired sample size is reached. A simple randomisation by means of computer generated numbers will be used to minimize selection bias. Both the study subjects and the investigators will be blinded to the allocation (treatment or placebo). The unblinding will be done only after the analysis has been completed.

Conditions

• Acute Lower Respiratory Tract Infection
• Pneumonia
• Bronchiolitis

Interventions

Type	Name	Description
DRUG	Vitamin D	Vitamin D 2 500 IU daily from enrolment (within 24 hours of hospitalization) until discharge from hospital

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-11-01
• Completion: 2015-01-01
• First posted: 2014-02-04
• Last updated: 2014-02-04

Locations

1 site across 1 country: South Africa