| CTRI Number |
CTRI/2025/06/089511 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Oral Zinc Supplementation in Neonatal Jaundice |
|
Scientific Title of Study
|
Effect of Zinc Oral Supplementation in Hyperbilirubinemia (ZOSH) on Serum Bilirubin Levels in Neonates Requiring Phototherapy: A Double-blind Randomized Controlled Trial |
| Trial Acronym |
ZOSH Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandra Prakash |
| Designation |
Junior Resident, Department of Pediatrics |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Pediatrics, AIIMS Raipur, Raipur, Chattisgarh.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9996495149 |
| Fax |
|
| Email |
dr.cp.dhs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tripty Singh |
| Designation |
Additional Proffessor, Department of Pediatrics |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Pediatrics, AIIMS Raipur, Raipur, Chattisgarh.
CHHATTISGARH
492099
India |
| Phone |
9826130218 |
| Fax |
|
| Email |
triptyn@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chandra Prakash |
| Designation |
Junior Resident, Department of Pediatrics |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Pediatrics, AIIMS Raipur, Raipur, Chattisgarh.
CHHATTISGARH
492099
India |
| Phone |
9996495149 |
| Fax |
|
| Email |
dr.cp.dhs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
Department of Pediatrics, AIIMS Raipur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chandra Prakash |
AIIMS Raipur |
Neonatal Intensive Care Unit (NICU)
Raipur
CHHATTISGARH |
9996495149
dr.cp.dhs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P590||Neonatal jaundice associated withpreterm delivery, (2) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
D10 |
same volume as intervention |
| Intervention |
Oral Zinc (20mg/5ml) |
1.25 ml Per oral in term neonates for 3 days and 0.25 ml per kg per oral for 3 days in pre term neonates |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All pre-term and term neonates admitted to NICU with hyperbilirubinemia for phototherapy |
|
| ExclusionCriteria |
| Details |
1. Neonates with direct hyperbilirubinemia
2. Neonates with other systemic illnesses, severe sepsis, severe respiratory disease requiring mechanical ventilation, oral intolerance, and major gross congenital anomalies .
3. Neonates whose parents refuse to give consent.
4. neonates requiring exchange transfusion at admission for hyperbilirubinemia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sequential levels of serum bilirubin during hospital stay at 24 hours and at time of discharge |
24 hours post start of phototherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of phototherapy (in hours)
2. Duration of hospital stay
3. Any adverse effect of Zinc
4. Readmission with the same symptoms
5. cost of therapy
|
24 hours after start of phototherapy, at the time of discharge & adverse effects at any time during the course of stay. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 4 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.cp.dhs@gmail.com].
- For how long will this data be available start date provided 31-03-2027 and end date provided 31-03-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Neonatal hyperbilirubinemia is one of the common causes of neonatal morbidity. It manifests with the rise of unconjugated bilirubin levels in the neonatal blood, which results in yellowish staining of the skin and sclera. The major contributing factors are the breakdown of RBCs, immaturity of neonates’ liver, lack of intestinal flora, and enhanced enterohepatic circulation (EHC). EHC contributes significantly to neonatal hyperbilirubinemia, and its blockage might be a therapeutic target for this condition. Zinc due to its bilirubin adsorbing properties has been studied in animal models to reduce EHC and serum zinc level in neonates is reported to be one of the factors affecting the severity and incidence of neonatal hyperbilirubinemia. Studies have shown that the use of zinc syrup in preterm infants with indirect hyperbilirubinemia significantly reduced bilirubin levels within 48 hours of treatment. However there are sporadic studies on the effect of zinc on the reduction of hyperbilirubinemia in pre-term neonates and much less in term neonates, therefore there is a need to research further the effects of zinc on hyperbilirubinemia in pre-term and term babies |