Vitamin D Supplementation for Severe Pneumonia in Under-five Childre

Phase 3

Completed

• Conditions: Health Condition 1: null- pneumoniaHealth Condition 2: J189- Pneumonia, unspecified organism

• Registration Number: CTRI/2013/01/003317
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-08-27
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 324

Inclusion Criteria

Children with severe pneumonia

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>2. Proportion of children having a repeat episode of pneumonia in next six months. <br/ ><br> <br/ ><br>Timepoint: 1. 7 days <br/ ><br>2. 6 months

Secondary Outcome Measures

Name	Time	Method
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