Vitamin-D Supplementation: Impact on Severe Pneumonia Among Under-five Children
Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
Summary
Background:
- Burden: Pneumonia is the leading cause of morbidity and mortality in under-five
children, particularly in developing countries.
- Knowledge gap: Although many studies have reported an association between vitamin D
deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e.
the impact of vitamin D supplementation in the management of childhood pneumonia.
- Relevance: Vitamin D plays an important role in modulating the innate immune response
against infections. We, therefore, propose to conduct this study to assess the impact of
vitamin D supplementation, in addition to standard antibiotic and supportive therapy, on
the outcome of severe childhood pneumonia.
Hypothesis: The investigators hypothesise that in the management of hospitalized severe
pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard
antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may
thereby shorten duration of severe pneumonia and also reduce the risk of new episode of
pneumonia.
Objectives: The objective of the investigators study is to assess the clinical benefit of
oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive
therapy, to hospitalised, under-five children with severe pneumonia.
Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children
of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically
diagnosed severe pneumonia will comprise the study population. Eligible children will be
allotted a sequential study number, which will have been previously assigned to vitamin D or
placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the
children will be blinded as to whether vitamin D3 or placebo has been added to their child's
diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6
months or older will receive "Milk Suji" as a complementary food. Vitamin D3 supplementation
will be given on five consecutive days, from the day of enrolment in addition to standard
antibiotic and other supportive therapy.
Outcome measures/variables:
Primary outcome measure will be time to resolution of severe pneumonia.
Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in
drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new
episode of pneumonia after discharge.
Phase:
Phase 1
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator:
Centers for Disease Control and Prevention
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins