| CTRI Number |
CTRI/2018/04/013287 [Registered on: 16/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
08/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Placebo] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Zinc in Sepsis |
|
Scientific Title of Study
|
Role of Zinc in Sepsis: A Randomized, Double blinded, Placebo controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalan Prasad Rauniyar |
| Designation |
Junior Resident |
| Affiliation |
B.P. Koirala Institute of Health Sciences |
| Address |
B.P. Koirala Institute of Health Sciences, Dharan-18, Nepal
00977
Other |
| Phone |
9842431530 |
| Fax |
|
| Email |
lpr3234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Gauri Shankar Shah |
| Designation |
Professor |
| Affiliation |
B.P. Koirala Institute of Health Sciences |
| Address |
B.P. Koirala Institute of Health Sciences, Dharan-18, Nepal
00977
Other |
| Phone |
9852062140 |
| Fax |
|
| Email |
gaurishankarshah@live.com |
|
Details of Contact Person
Public Query
|
| Name |
Lalan Prasad Rauniyar |
| Designation |
Junior Resident |
| Affiliation |
B.P. Koirala Institute of Health Sciences |
| Address |
B.P. Koirala Institute of Health Sciences, Dharan-18, Nepal
00977
Other |
| Phone |
9842431530 |
| Fax |
|
| Email |
lpr3234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deurali-Janta Pharmaceutical Private Limited, Hattisar, Kamalpokhari, G.P.O. Box: 4239, Kathmandu, Nepal |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lalan Prasad Rauniyar |
B.P.Koirala Institute of Health Sciences, Nepal |
Department of Pediatrics and Adolescent Medicine
|
9842431530
lpr3234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Committee (IRC), Institutional ethical review board, B. P. Koirala Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
1tabet PO OD for 14 days |
| Intervention |
Zinc |
1 Tablet(20 mg) PO OD for 14 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All children of 1 year to 15 years admitted to Paediatric ward/PICU in one year duration. |
|
| ExclusionCriteria |
| Details |
- Children without assent.
- Children with immunocompromised state.
- Children with inborn error of metabolism.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the benefit of Zinc supplementation on mortality in children diagnosed as sepsis. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effect of zinc supplementation on duration of hospital stay, need for higher antibiotics, need for inotropes, need for blood component and mechanical ventilation. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="0"
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 1 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/04/2017 |
| 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)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The children diagnosed as sepsis recruited into the study were assigned to the study group and the Placebo group using computer generated randomization tables, blinded to both the patient and the investigators. The drugs (Zinc) as well as the Placebo were made available by the reputed Pharmaceutical company. The formulation was given to the children for duration of 14 days along with the standard antimicrobial therapy and outcomes were recorded during discharge and on follow up. |