Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Vitamin D Supplementation: Impact on Severe Pneumonia Among Under-five Children
Brief 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.


Options:
A: Arm Label: vitamin D3 supplementation; Type: EXPERIMENTAL; Interventions: Drug: A single one ml injection | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: A single one ml injection | Intervention Type: DRUG; Name: A single one ml injection; Assigned to Arm(s): Placebo, vitamin D3 supplementation
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: vitamin D | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
C: Arm Label: Vitamin D3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin D3 | Arm Label: Miglyol-oil; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Vitamin D3; Assigned to Arm(s): Vitamin D3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Miglyol-oil
D: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D3 | Arm Label: Control; Type: OTHER; Interventions: Dietary Supplement: Vitamin D3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Treatment | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Control

Answer: C