Vitamin-D Supplementation: Impact on Severe Pneumonia Among Under-five Children

Hypothesis to be tested:

In a hypothesis testing research proposal, briefly mention the hypothesis to be tested and provide the scientific basis of the hypothesis, critically examining the observations leading to the formulation of the hypothesis.

Does this research proposal involve testing of hypothesis: 0 No 1 Yes (describe below)

The investigators hypothesise that supplementation of vitamin D3 (Cholecalciferol), in addition to standard antibiotic and other supportive therapy in the management of under-five children with severe pneumonia will significantly shorten the duration of severity of pneumonia and thereby reduce hospital stay and also reduce the risk of new episode of pneumonia.

Specific Objectives:

Objective: To assess the clinical benefit of oral vitamin D3 supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalised, under-five children with severe pneumonia.

Primary objective: To compare the duration of severe pneumonia of children in the two study groups receiving the standard therapy (appropriate antibiotic and other supportive therapy) with those receiving vitamin D supplementation in addition to the standard therapy.

Secondary objectives:

• To compare the duration of hospitalization, fever, tachypnoea, chest in drawing, hypoxia, lethargy and inability to feed during hospital stay, in under-five children in the two study groups, as mentioned under the primary aim.
• To compare the recurrence of new episode of pneumonia over the next 6 months after discharge from hospital in the two study groups.
• To identify the optimum safety dose of vitamin D3 for different groups of under-five children.
• In severe pneumonia patient who also have acute watery diarrhoea we will assess the indirect absorption of vitamin D by measuring serum vitamin D level and will also assess the clinical outcome in the subgroup.

Inclusion criteria

• Children of either sex aged 3 - 59 months, with a clinical diagnosis of severe pneumonia with or without diarrhea.

Exclusion criteria

• Known case of hypercalcaemia or allergy to vitamin D, as determined by history or previous medical records.
• Congenital Heart disease, evidenced by clinical exam or past medical records.
• Renal or hepatic insufficiency, evidenced by clinical exams or past medical records.
• Known case of tuberculosis, evidenced by medical records
• Known case of asthma, evidenced by history and clinical exam findings.
• Critically ill children requiring ICU care, such as those with septic shock or cardiac arrest or apnoea.
• Received vitamin D or calcium supplementation within the last 4 weeks before current admission, as evidenced by history or medical prescription.
• Any children diagnosed as hypernatraemia during the main phase of the study.