Role for Vitamin A and Zinc in treatment of children with pneumonia

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/03/003463
• Date of registration: 08-03-2013
• Prospective Registration: Yes
• Primary sponsor: JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH
• Public title: Role for Vitamin A and Zinc in treatment of children with pneumonia
• Scientific title: Vitamin A and Zinc as adjuncts in treatment of children with acute lower respiratory tract infection
• Date of first enrolment: 01-04-2013
• Target sample size: 320
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6059
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Neha
• Affiliation: JIPMER

• Name: Dr Adhisivam B
• Affiliation: JIPMER

Key inclusion & exclusion criteria

Inclusion criteria: All the children admitted with acute lower respiratory tract infection (ALRI) will be enrolled in the study provided the inclusion & exclusion criteria have been met.
Exclusion criteria: 1. Children who are <2months old and > 5yrs.

2. Children who have received Vitamin A or zinc in last 2 months.

3. Children who are suffering from measles associated pneumonia, and non infectious etiologies of pneumonia such as oil instillation/kerosene aspiration.

4. Presence of chronic lung disease (bronchiectasis, chronic cough)

5. Presence of other significant systemic diseases

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- children with acute lower respiratory tract infection

Intervention(s)

Intervention1: Zinc: Tab Zinc sulfate oral for 5 days
dose 10 mg od for less than 6 months of age and 20 mg od for more than 6 months of age
Intervention2: vitamin A: Tab vitamin A chewable less than 6 months 50,000 IU STAT
more than 6 months age 50,000 IU OD for 2 days
more than 12 months 1 lac IU OD for 2 days

Control Intervention1: no adjuncts: one group will receive only antibiotics as per standard protocol with no adjuncts

Primary Outcome(s)

. Time taken for resolution of symptoms of severe pneumonia

.Duration of hospital stay.

.Incidence of readmission.

. Need for ICU admission

. Occurrence of complications (empyema, pleural effusion, dissemination to other organs)

. Oxygen requirement and SpO2 changes.

. Mortality if any.

Timepoint: till discharge

Secondary Outcome(s)

Readmission with LRI within 3months of dischargeTimepoint: 3months of discharge

Secondary ID(s)

NIL

Source(s) of Monetary Support

Nil

Ethics review

Status: Approved
Approval date: 09/11/2012
Contact:

Institute ethics committee (human studies)