Clinical trial NCT02054182: Effect of Vitamin D Supplementation in Young South African Children Hospitalized With Acute Lower Respiratory Infection
Official title: Effect of Vitamin D Supplementation in Young Children With Acute Lower Respiratory Tract Infection at Dr George Mukhari Academic Hospital, Pretoria, South Africa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Lower Respiratory Tract Infection
Pneumonia
Bronchiolitis
Keywords: vitamin D supplementation, pneumonia, bronchiolitis
Lead sponsor: University of Limpopo
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All children age 1month - 5 yrs, admitted in the paediatric unit of Dr George Mukhari Hospital with an acute lower respiratory tract infection i.e. bronchiolitis and/ or pneumonia

Exclusion Criteria:

* Children whose caregivers decline participation in the study Children with co-morbid chronic respiratory condition(s) Children who have received vitamin D supplementation in the past 30 days

Primary outcomes:
measure: Comparison of change from baseline in modified Respiratory Distress Assessment Instrument score at hospital discharge between vitamin D supplement and placebo groups.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes:
measure: Comparison of duration of hospitalization between vitamin D supplementation and placebo groups.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other outcomes:
measure: Assessment of correlation between vitamin D levels and modified Respiratory Distress Assessment Instrument score
timeFrame: On day 1, i.e. date of randomization
Locations:
city: Pretoria
country: South Africa
facility: Dr George Mukhari Academic Hospital
state: Gauteng
Study officials:
affiliation: Univeristy of Limpopo, Medunsa Campus
name: Siyazi Mda, MBChB, PhD
role: STUDY_CHAIR
References: