| CTRI Number |
CTRI/2018/08/015245 [Registered on: 09/08/2018] Trial Registered Prospectively |
| Last Modified On: |
04/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Supplement] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Study Whether Zinc Supplement Has Got Any Beneficial Effect In Neonatal Hyperbilirubinemia.
|
|
Scientific Title of Study
|
Study Of Role Of Oral Zinc Supplement In Neonatal Hyperbilirubinemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejas Hukumchand Mandlecha |
| Designation |
Junior Resident |
| Affiliation |
G.M.C.AURANGABAD |
| Address |
Department Of Paediatrics
G.M.C.H.Aurangabad.
Department Of Paediatrics
G.M.C.H.Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7588531896 |
| Fax |
|
| Email |
tejasjain17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P S Patil |
| Designation |
Head Of Department |
| Affiliation |
G.M.C.AURANGABAD |
| Address |
Department Of Paediatrics
G.M.C.H.Aurangabad.
Department Of Paediatrics
G.M.C.H.Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822424006 |
| Fax |
|
| Email |
dr_prashantpatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejas Hukumchand Mandlecha |
| Designation |
Junior Resident |
| Affiliation |
G.M.C.AURANGABAD |
| Address |
Department Of Paediatrics
G.M.C.H.Aurangabad.
Department Of Paediatrics
G.M.C.H.Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
07588531896 |
| Fax |
|
| Email |
tejasjain17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Paediatrics
G.M.C.H.Aurangabad. |
|
|
Primary Sponsor
|
| Name |
Tejas Hukumchand Mandlecha |
| Address |
Department Of Paediatrics
G.M.C.H.Aurangabad. |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Tejas Hukumchand Mandlecha |
GOVERNMENT MEDICAL COLLAGE AURANGABAD |
Department Of Paediatrics, Government medical collage, university road ,jubli park,431001.
Aurangabad
MAHARASHTRA |
7588531896
tejasjain17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neonates with neonatal hyperbilirubinemia within phototherapy range. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dextrose 10 % |
I am supplementing Dextrose 10% to one group as a placebo. |
| Intervention |
Zinc |
Zinc preparations are given as ZINC SULPHATE in 8 mg Two divided doses
Within the limits of rda.
will provide 2 mg of elemental zinc |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All term neonate(>38wk) presented with indirect hyperbilirubinemia within phototherapy range |
|
| ExclusionCriteria |
| Details |
1- Preterm neonate
2- neonates with DIRECT HYPERBILIRUBINEMIA
3 – neonate requiring EXCHAGE TRANSFUSION at any point of time during study
4.All cases with
Sepsis at the time of enrollment,
severe respiratory disease requiring mechanical ventilation,
congenital anomalies
5-patient who refuses to continue are excluded from study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study Role Of Oral Zinc Sulphate Supplementation In Reduction Of Indirect Hyperbilirubinemia Term Neonate (more than 38 wk). |
Use Of Zinc Till The Reduction Of Serum Bilirubine Below Phototherapy Range. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.TO STUDY THE EFFECT OF ORAL ZINC SULPHATE IN EARLY DISCHARGE IN TERM NEONATE(38).
2.TO STUDY SIDE EFFECTS OF ZINC SUPPLEMENTATION |
Clinical recovery |
|
|
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)
|
15/08/2018 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Zinc is one of the essential component in neonatal growth, protein synthesis and many other pathway. It has been shown to lower the serum Bilirubine level by inhibition of normal enterohepatic cycling of unconjugated bilirubin. Therefore, the anticipated role of oral zinc supplementation in neonatal jaundice seems to be attractive. This radamised clinical trial will be conducted on term neonate to characterize the role of zinc sulfate in neonatal hyperbilirubinemia. |