| CTRI Number |
CTRI/2024/08/071828 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of Oral Zinc Supplementation on Serum Bilirubin Levels in Neonates with Hyperbilirubinemia Undergoing Phototherapy: An Open-Label Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Oral Zinc Supplimentation On Serum Bilirubin Levels In Neonates With Hyperbilirubinemia Undergoing Phototherapy : A Open Labeled, Randomised Controlled Trail. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supreeth sv |
| Designation |
1 st junior resident |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
Sri Devaraj urs medical college, Tamaka , Kolar, 563101
Department for paediatric, paediatric Opd , room no 24
Kolar
KARNATAKA
563101
India |
| Phone |
9066245091 |
| Fax |
|
| Email |
supreethsv88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KNV PRASAD |
| Designation |
Professor department of paediatrics |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
Sri Devaraj urs medical college, Tamaka , Kolar, 563101, department of paediatrics , room no 24
Sri Devaraj urs medical college, Tamaka, department of paediatrics , Room no -24
Kolar
KARNATAKA
563101
India |
| Phone |
9740551490 |
| Fax |
|
| Email |
drknvp@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supreeth sv |
| Designation |
1 st junior resident |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
Sri Devaraj urs medical college, Tamaka , Kolar, 563101
Department for paediatrics, paediatric Opd , room no 24
Kolar
KARNATAKA
563101
India |
| Phone |
9066245091 |
| Fax |
|
| Email |
supreethsv88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College, TAMAKA, Kolar PIN code 563103 |
|
|
Primary Sponsor
|
| Name |
Dr Supreeth sv |
| Address |
Sri Devaraj urs medical college PGMH , Tamaka , Kolar-563101 |
| 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 |
| Dr Supreeth SV |
Sri Devaraj urs medical college |
Sri Devaraj urs medical college, Tamaka , Kolar, department for paediatrics, room no 24
Kolar
KARNATAKA |
9066245091
supreethsv88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| central 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 |
| Comparator Agent |
5% sucrose |
Neonates will be allocated into two groups, the Zinc group and the Placebo group, by generating a random sequence using permutated blocks of 10 each. Allocation concealment will be achieved using sequentially numbered opaque sealed envelopes and will be done by a researcher who will not be involved in the drug administration or assessment. Neonates in both groups will receive phototherapy (single surface phototherapy). The phototherapy devices will be the same in both groups and will be calibrated for each patient.
In addition to phototherapy, the Zinc group will receive 5 mg elemental zinc, i.e., 0.25 mL (syrup containing 20 mg/mL zinc sulfate). The Placebo group will receive 0.25 mL solution (5% sucrose). The placebo and zinc sulfate bottles will be identical in volume, color, appearance, and packaging. A syringe will be used for oral administration. Zinc and placebo syrups will be coded and blinded to the participants, investigator, and statistician until the analysis is complete. Nurses will administer the drug upon the researcher’s prescription.
|
| Intervention |
zinc supplementation |
Neonates will be allocated into two groups, the Zinc group and the Placebo group, by generating a random sequence using permutated blocks of 10 each. Allocation concealment will be achieved using sequentially numbered opaque sealed envelopes and will be done by a researcher who will not be involved in the drug administration or assessment. Neonates in both groups will receive phototherapy (single surface phototherapy). The phototherapy devices will be the same in both groups and will be calibrated for each patient.
In addition to phototherapy, the Zinc group will receive 5 mg elemental zinc, i.e., 0.25 mL (syrup containing 20 mg/mL zinc sulfate). The Placebo group will receive 0.25 mL solution (5% sucrose). The placebo and zinc sulfate bottles will be identical in volume, color, appearance, and packaging. A syringe will be used for oral administration. Zinc and placebo syrups will be coded and blinded to the participants, investigator, and statistician until the analysis is complete. Nurses will administer the drug upon the researcher’s prescription.
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
10.00 Day(s) |
| Gender |
Both |
| Details |
All late preterm(≥35weeks), term, post term neonates admitted with hyperbilirubinemia in phototherapy range. |
|
| ExclusionCriteria |
| Details |
Neonates with direct hyperbilirubinemia
• Major gross congenital anomalies (gastrointerstinal malformations, heart defects, neural tube defects) and with identifiable genetic syndromes.
• Preterm neonate(≥35weeks), who are already started on zinc supplementation
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of oral zinc on serum bilirubin levels in neonates with hyperbilirubinemia undergoing at phototherapy
To correlate the effect of oral zinc and duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy at baseline |
To evaluate the effect of oral zinc on serum bilirubin levels in neonates with hyperbilirubinemia undergoing at 5 daysphototherapy
To correlate the effect of oral zinc and duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the effect of oral zinc & duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy at 5 days |
To correlate the effect of oral zinc & duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy at 5 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2024 |
| 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 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
|
Dr. Supreeth SV from Sri Devaraj Urs Medical College aims to study the impact of oral zinc supplementation on serum bilirubin levels in neonates with hyperbilirubinemia undergoing phototherapy. Neonatal jaundice, caused by bilirubin accumulation, can lead to serious neurological complications if untreated. Zinc may reduce bilirubin levels by blocking its production. Previous studies suggest zinc’s efficacy in reducing phototherapy duration. This open-label randomized controlled trial will include late preterm to post-term neonates. Data will be collected from RL Jalappa Hospital over 18 months. Ethical clearance has been obtined, with CTRI registration in progress. Statistical analysis will utilize SPSS software. |