| CTRI Number |
CTRI/2022/09/045346 [Registered on: 08/09/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of prophylactic zinc in prevention of respiratory infections and Diarrhoea among children. |
|
Scientific Title of Study
|
Evaluation of efficacy of prophylactic intermittent zinc supplementation in reducing the incidence of acute lower respiratory infections and acute diarrhoea in infants: A hospital based, open label randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arnab Ghorui |
| Designation |
Junior Resident(Academic), Paediatrics |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Paediatrics,IPD building, AIIMS,Phulwarisharif , Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
08759948784 |
| Fax |
|
| Email |
arnabmck999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Mohan Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Paediatrics , IPD Building, AIIMS, Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
9810730206 |
| Fax |
|
| Email |
cmkumar@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandra Mohan Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Paediatrics , IPD Building, AIIMS,Phulwarisharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
9810730206 |
| Fax |
|
| Email |
cmkumar@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
Dr Arnab Ghorui |
| Address |
Junior Resident, Department of Paediatrics, AIIMS, Patna |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arnab Ghorui |
All India Institute of Medical Sciences, Patna |
Immunization clinic , Pediatrics OPD, AIIMS, Patna
Patna
BIHAR |
8759948784
arnabmck999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of All India Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healty infants of age between 6 wks to 6 months, coming for routine vaccination as per National Immunization Schedule |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Prophylactic Zinc Supplementation |
Drop Z and D (20mg/ml)
0.5ml PO OD 2wks
At first and second visits |
| Comparator Agent |
Oral Zinc free multivitamin |
Drop Vi Syneral
0.5ml PO OD 2wks
At first and second visits |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Infants of age between 6 wks to 6 months coming for vaccination as per National Immunization Schedule |
|
| ExclusionCriteria |
| Details |
1. Children received zinc supplementation in past 2months
2. Children with severe illness requiring hospitalization
3. Infants with weight and height for age < -3 SD
Suspected Malabsorption syndrome |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effect of prophylactic zinc supplementation in the incidence, duration and severity of Diarrhoea and ALRI among infants |
First follow up at 1 month
2nd follow up 3 months after the first follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out effect of zinc on growth of infants |
First follow up at 1 month
2nd follow up 3 months after the first follow up |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arnabmck999@gmail.com].
- For how long will this data be available start date provided 29-01-2023 and end date provided 29-04-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Study procedure: Approval will
be obtained from the institutional research committee and institutional ethics
committee. All infants of age
between 6 weeks to 6 months visiting at Pediatric medicine OPD of AIIMS, Patna
for 6wk or 10 wk Vaccination as per NIS and whose mother /caregiver provides
consent will be enrolled in the study. Then screening will be done to assess for
eligibility and anthropometry will be done. Then participants will be allocated
in intervention group or control group by means of random allocation using
block randomization technique with sealed envelope. In the intervention group
zinc supplements will be given for 2wks (Drop Z&D) and in the control group
zinc free multivitamin will be given for 2wks (Drop Vi Syneral) along with this
follow up diary card will be provided to both the groups to note all diarrhoea and ALRI episodes and anthropometric data. Next participants
will be physically followed up after 1 month during next vaccination, zinc and
multivitamin supplements will be repeated for another 2 wks and follow-up diary
will be reviewed and arthrometry will be done and data will be entered in the
database. Finally participants will be telephonically/physically followed up
after 3 months and database will be updated. Total incidence, duration and
severity of Diarrhea and ALRI along with gain in length will be estimated in
both the groups after final follow up and analysis will be done. |