| CTRI Number |
CTRI/2026/02/102916 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Does giving zinc help reduce jaundice in newborn babies receiving light treatment |
|
Scientific Title of Study
|
Effect of oral zinc supplementation on serum bilirubin level in term neonates undergoing phototherapy a double blind randomized placebo controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hinal doshi |
| Designation |
Junior resident |
| Affiliation |
Pacific institute of medical sciences |
| Address |
Department of pediatrics pacific institute of medical sciences umarda udaipur
Udaipur
RAJASTHAN
313005
India |
| Phone |
9549232425 |
| Fax |
|
| Email |
hinaldoshi.1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vivek parasher |
| Designation |
Head of department |
| Affiliation |
Pacific institute of medical sciences |
| Address |
Department of pediatrics pacific institute of medical sciences umarda udaipur
Udaipur
RAJASTHAN
313005
India |
| Phone |
98295 93478 |
| Fax |
|
| Email |
Vivek.parasher80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hinal doshi |
| Designation |
Junior resident |
| Affiliation |
Pacific institute of medical sciences |
| Address |
Department of pediatrics pacific institute of medical sciences umarda udaipur
Udaipur
RAJASTHAN
313005
India |
| Phone |
9549232425 |
| Fax |
|
| Email |
hinaldoshi.1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific institute of medical sciences umarda udaipur rajasthan india 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific institute of medical sciences |
| Address |
Pacific institute of medical sciences umarda udaipur rajasthan india 313001 |
| Type of Sponsor |
Private medical college |
|
|
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 hinal doshi |
Pacific institute of medical sciences |
Room number 110 department of pediatrics
Udaipur
RAJASTHAN |
9549232425
hinaldoshi.1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee sai tirupati university udaipur rajasthan india |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral zinc sulphate |
Oral zinc sulphate at a dose of 10mg per day in two divided doses along with standard phototherapy |
| Comparator Agent |
Sucrose |
Placebo in the form of oral sucrose solution identical in appearance and volume to zinc prepartion |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
All healthy term neonates ( 38 to 42 weeks )
Age less then 7 days
Total bilirubin in range ( 15 to 25 mg per dl )
Parental consent obtained |
|
| ExclusionCriteria |
| Details |
Neonates with sepis or conjugated hyperbilirubinemia or rds or cephalohematoma or birth asphyxia
Pre term neonates ( less than 38 weeks )
Post term neonates ( more than 41 weeks )
Congenital anomalies
Neonates already on zinc therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We need to observe if after giving zinc therapy to neonates will serum bilirubin level decrease gradually or not |
At day 1 day 3 and day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/03/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The thesis investigates the need of zinc in term neonates on serum bilirubin level undergoing phototherapy. prolonged exposure to phototherapy can lead to increased insensible water loss dehydration electrolytes imbalance increase stool frequency retinal toxicity interference with maternal infant bonding extended duration of hospital stay. zinc an essential trace element plays an important role in cellular metabolism and immune function it can reduce serum bilirubin levels by inhibiting enterohepatic circulation. zinc has been proposed as a useful adjunct in the management of neonatal hyperbilirubinemia hence this study is planned to evaluate the effect of oral zinc supplementation on serum bilirubin levels in term neonates undergoing phototherapy. |