| CTRI Number |
CTRI/2025/09/094993 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of oral zinc supplementation for term neonates with jaundice receiving phototherapy |
|
Scientific Title of Study
|
Effectiveness of oral zinc supplementation for term neonates with hyperbilirubinemia receiving phototherapy : A Randomized 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 |
P Rohit |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Paediatric department room no 5 Aarupadai veedu medical College and hospital Cuddalore main road kirumampakkam puducherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7337889712 |
| Fax |
|
| Email |
rohitpogal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr chandru bhaskar |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Paediatric department room no 5 Aarupadai veedu medical college pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8317365885 |
| Fax |
|
| Email |
chandru14885@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr chandru bhaskar |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Paediatric department room no 5 Aarupadai veedu medical College and hospital
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8317365885 |
| Fax |
|
| Email |
chandru14885@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607403 india |
|
|
Primary Sponsor
|
| Name |
P ROHIT |
| Address |
Aarupadai Veedu Medical College Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607403 india |
| 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 |
| P ROHIT |
Aarupadai veedu medical College and Hospital |
Paediatric department room no 5 Aarupadai veedu medical College and hospital
Pondicherry
PONDICHERRY |
7337889712
rohitpogal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayak missions research foundation institutional human ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral zinc supplementation
5mg/kg once a day
For 3 days |
Oral zinc supplementation
5mg / kg
Once a day
Oral
For 3 days |
| Intervention |
Oral zinc supplementation |
Oral zinc supplementation of 5mg/day in newborn with hyperbilirubinemia requiring phototherapy for 3 days once a day |
| Comparator Agent |
Photography |
Photography in hyperbilirubinemia neonates
3 days
Method with is universally followed |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
Neonates with hyperbilirubinemia |
|
| ExclusionCriteria |
| Details |
Preterm neonates
Pathological hyperbilirubinemia
Systematic illness
Sepsis |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of oral zinc supplementation in term neonates with hyperbilirubinemia requiring phototherapy |
Every 24 hr till bilirubin level falls below danger level
Reports ll be compared at the end of study
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of hospital stay |
3 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/09/2025 |
| 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)
|
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
|
To study the effectiveness and safety of oral zinc supplementation in term neonates with hyperbilirubinemia requiring phototherapy . Admitted in nicu ,and hospital stay |