| CTRI Number |
CTRI/2009/091/000040 [Registered on: 06/02/2009] |
| Last Modified On: |
08/10/2012 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of zinc supplementation in children with fast breathing and breathing difficulty |
|
Scientific Title of Study
|
Zinc Supplementation in Acute Lower Respiratory Tract Infection in Children: A Randomized Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuradha Bansal |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pediatrics
Government Medical College Hospital
Chandigarh
CHANDIGARH
160030
India |
| Phone |
0172-2665253-60-2503 |
| Fax |
0172-2609360 |
| Email |
dranuradhabansal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Chawla |
| Designation |
|
| Affiliation |
Government Medical College Hospital |
| Address |
Department of Pediatrics
Government Medical College Hospital
Chandigarh
CHANDIGARH
160030
India |
| Phone |
0172-2665253-60-2503 |
| Fax |
0172-2609360 |
| Email |
drdeepakchawla@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Chawla |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pediatrics
Government Medical College Hospital
Chandigarh
CHANDIGARH
160030
India |
| Phone |
0172-2665253-60-2503 |
| Fax |
0172-2609360 |
| Email |
drdeepakchawla@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
|
| Type of Sponsor |
|
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anuradha Bansal |
Department of Pediatrics |
Government Medical College Hospital,-160030
Chandigarh
CHANDIGARH |
+91-172-2665545-49, 2665253-60, Extension 2503
+91-172-2608488
dranuradhabansal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Severe acute lower respiratory tract infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
|
| Intervention |
Zinc |
20 mg once a day orally for 5 days |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Children aged 2-24 months presenting with tachypnoea and either chest retractions or one of the following danger signs: cyanosis, inability to feed/drink, lethargy and convulsions |
|
| ExclusionCriteria |
| Details |
Children with concurrent diarrhea, severe malnutrition (weight for age <50% of reference value), congenital heart disease and those already on zinc supplements were excluded |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to be asymptomatic |
defined as resolution of all four of the following: respiratory distress, tachypnoea, hypoxia in room air and systemic danger signs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of hospital stay |
measured at discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/04/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
Publication Details
Modification(s)
|
http://www.ncbi.nlm.nih.gov/pubmed/20882421 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomized, blinded study for evaluating the effect of zinc supplementation on duration of illness in children aged 2-24 months with severe acute lower respiratory tract infection. Primary outcome is time to be asymptomatic which is defined as resolution of all four of the following: respiratory distress, tachypnoea, hypoxia in room air and systemic danger signs |