| CTRI Number |
CTRI/2025/10/095855 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of oral zinc supplementation in reducing bilirubin levels in babies requiring phototherapy |
|
Scientific Title of Study
|
Effect of Oral Zinc supplementation on Serum Bilirubin Levels in Late preterm and Term Neonates Undergoing 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 |
Venigandla Nagaraju |
| Designation |
Junior resident |
| Affiliation |
Sri venkateshwaraa medical college hospital and research centre |
| Address |
Department of paediatrics sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry
Department of paediatrics sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8074221065 |
| Fax |
|
| Email |
nagarajuvenigandla53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.E. vijayabharathi |
| Designation |
Associate professor |
| Affiliation |
Sri venkateshwaraa medical college hospital and research centre |
| Address |
Department of paediatrics sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry
Department of paediatrics sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442605567 |
| Fax |
|
| Email |
drviba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.E.vijayabharathi |
| Designation |
Associate professor |
| Affiliation |
Sri venkateshwaraa medical college hospital and research centre |
| Address |
Department of paediatrics sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry
Department of paediatrics sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442605567 |
| Fax |
|
| Email |
drviba@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Venigandla Nagaraju Principal Investigator |
| Address |
Department of Paediatrics Villupuram main road sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry |
| 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 |
| Venigandla Nagaraju |
Neonatal Intensive Care Unit |
Department of Paediatrics 3-A C block 218 flat number Villupuram main road sri Venkateshwaraa medical college hospital and research centre 605107 Ariyur Puducherry
Pondicherry
PONDICHERRY |
8074221065
nagarajuvenigandla53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 For Neonates Requiring Phototherapy |
Oral zinc Acetate 5MG/day(0.25ml) Twice daily for 3 days for neonates requiring phototherapy |
| Comparator Agent |
Placebo Distilled water |
Placebo Distilled water 0.25ML Twice daily for 3 days for neonates undergoing phototherapy |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
All healthy late preterm and term neonates requiring phototherapy within 7 days of life |
|
| ExclusionCriteria |
| Details |
Preterm neonates of less than 34 weeks
Neonates with direct hyperbilirubinemia
Severe sepsis
Hemolytic jaundice |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of zinc on serum bilirubin in late preterm and tern neonates with hyperbilirubinemia undergoing phototherapy |
12th hourly, 24th hourly, 48th hourly after starting phototherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the duration of phototherapy |
7 days |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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)
|
20/10/2025 |
| 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="8"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aim of the study is to evaluate the effect of oral zinc on serum bilirubin levels in late preterm and term neonates undergoing phototherapy and also its relation to the duration of phototherapy and duration of hospital stay |