Health Condition 1: null- pneumonia Health Condition 2: J189- Pneumonia, unspecified organism
Conditions
Interventions
Intervention1: vitamin D: Single oral dose of 100,000 IU at enrolment
Control Intervention1: Placebo: Identically colored and packaged inert powder single dose at enrolment
Control Intervention2: Plac
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Children with severe pneumonia
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Children who have received vitamin D or calcium supplements within last 4 weeks, as ascertained on verbal enquiry (ingestion of oral formulation as sachets/granules or syrups or tablets). Where ever possible the parents will be asked to show the prescription of the physician or empty bottles, sachets or tablets consumed by the child. 2. Children with clinical features of rickets 3. Children with severe malnutrition (weight for height less than -3 SD of WHO standards or presence of bipedal edema) 4. Known asthmatics 5. Those with complicated pneumonia (lung abscess, pleural effusion, empyema) or illness severe enough to require ventilation. 6. Those suffering from any chronic respiratory disease including respiratory tract malformations and chest wall deformities, heart disease (congenital/acquired), renal or hepatic insufficiency, neurological illness resulting in abnormalities of muscle tone/power 7. Those known to have hypercalcemia or allergy to vitamin D 8. Children immunized with pneumococcal/flu vaccine 9. Known immunodeficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to resolution of severe pneumonia: The duration from the enrolment till the chest indrawing is no longer present, and continue to be absent for next 24 hours. 2. Proportion of children having a repeat episode of pneumonia in next six months. Timepoint: 1. 7 days 2. 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum levels of cathelicidinTimepoint: 72 hours;Change in serum levels of immunoglobulins (Ig A, IgG, IgM)Timepoint: 72 hours;Duration of hospitalizationTimepoint: At discharge;Failure rate (Non-response after 48 hours of antibiotic therapy)Timepoint: 48 hours;Fever clearance timeTimepoint: 7 days;Time to complete recovery from pneumonia (Normalization of RR)Timepoint: 7 days;Time to start oral feedsTimepoint: 7 days | — |
Countries
India
Contacts
Public ContactPiyush Gupta
University College of Medical Sciences
Outcome results
None listed