Pneumonia Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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