| CTRI Number |
CTRI/2026/01/100084 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Oral Zinc Supplementation in Preterm Neonates |
|
Scientific Title of Study
|
A Randomised Placebo Controlled Double Blinded Study Of Oral Zinc supplementation in Preterm Neonates with Indirect Hyperbilirubinemia |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakshitha V |
| Designation |
Postgraduate Resident |
| Affiliation |
KIMS Hospital and research Center |
| Address |
KIMS HOSPITAL AND RESEARCH CENTER
Krishna Rajendra Road,Parvathipuram,Vishweshwarapura,Shankarapura, Bengaluru , Karnataka
Krishna Rajendra road,Parvathipuram,Vishweshwarapura,Shankarapura, Bengaluru ,Karnataka
Bangalore
KARNATAKA
560004
India |
| Phone |
9482414030 |
| Fax |
|
| Email |
vrakshitha658@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil B |
| Designation |
Professor |
| Affiliation |
KIMS Hospital and research center |
| Address |
KIMS Hospital and Research Centre
Krishna Rajendra Road, Parvathipura,Shankarapura,Bengaluru
Bangalore
KARNATAKA
560040
India |
| Phone |
9900485879 |
| Fax |
|
| Email |
docsunilb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil B |
| Designation |
Professor |
| Affiliation |
KIMS Hospital and research center |
| Address |
KIMS Hospital and Research Centre
krishna Rajendra road, Vishweshwarapura, SHANKA
Bangalore
KARNATAKA
560040
India |
| Phone |
9900485879 |
| Fax |
|
| Email |
docsunilb@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIMS Hospital and research center, Krishna rajendra road , Parvathipuram ,Bengaluru , karnataka ,560004 |
|
|
Primary Sponsor
|
| Name |
Rakshitha V |
| Address |
Sunku Layout ,Mulbagal, Kolar District, Karnataka, 563131 |
| 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 |
| RAKSHITHA V |
KIMS hospital and research center |
Neonatal intensive care unit , Pediatric Department, KIMS HOSPITAL
Krishna rajendra road Parvathipuram Vishwesharapura , Shankarapura bangalore 560004
Bangalore
KARNATAKA |
9482414030
vrakshitha658@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KEMPEGOWDAINSTITUTEOFMEDICALSCIENCESINSTITUTIONALETHICALCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P590||Neonatal jaundice associated withpreterm delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NORMAL SALINE |
NORMAL SALINE 0.5ML TWICE DAILY FOR 3 DAYS |
| Intervention |
ORAL ZINC Sulphate |
Oral Zinc Sulphate 0.5ML Twice Daily FOR Three Days In Preterm With Indirect Hyperbilirubinemia
Study period -18 months |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
8.00 Month(s) |
| Gender |
Both |
| Details |
Preterm Neonates With Indirect Hyperbilirubinemia |
|
| ExclusionCriteria |
| Details |
RH INCOMPATIBILITY
TERM NEONATES
SEPSIS |
|
|
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 |
| Levels of serum bilirubin at Baseline,24hours and 48 hours |
Levels of serum bilirubin at Baseline, 24 hours and 48 hours |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2026 |
| 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="1" |
|
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
|
PRETERM NEONATS WITH INDIRECTHYPERBILIRUBINEMIA AFTER APPLYING INCLUSIO AND EXCLUSION CRITERIA ARE RANDOMLY ASSIGNED TO 2 GROUPS ONE IS INTERVENTIONAL AND OTHER IS PLACEBO GROUP AND GIVE ORAL SYRUP ZINC SULPHATE OR NORMAL SALINE 0.5ML TWICE DAILY UNTIL BILIRUBIN FALLS BELOW PHOTO THERAPY RANGE AND MEASURE TOTAL AND INDIRECT BILIRUBIN LEVELS BETWEEN TWO GROUPS AT 24 HOURS AND 48 HOURS OF INTERVENTION |