| CTRI Number |
CTRI/2023/02/049596 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Manganese citrate in neonates with hyperbilirubinemia |
|
Scientific Title of Study
|
A randomized double blinded phototherapy controlled crossover clinical trial to compare the efficacy of Manganese citrate 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 |
Prof Asim Kumar Mallick |
| Designation |
Professor and In-charge Neonatal Unit |
| Affiliation |
Department of Paediatric Medicine, Nil Ratan Sircar Medical College and Hospital |
| Address |
Room No. 202, Second Floor, Department of Paediatric Medicine, Neonatal Unit, Nil Ratan Sircar Medical College and Hospital
138, Acharya Jagadish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014.
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830008057 |
| Fax |
|
| Email |
nrsprojectdrmallick2021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Samir Kumar Pal |
| Designation |
Senior Professor |
| Affiliation |
Chemical, Biological and Macromolecular Sciences, S.N.Bose National Centre for Basic Sciences |
| Address |
Room No. 312, Second Floor, Department of Chemical, Biological and Macromolecular Sciences, Experimental Sciences,
S.N.Bose National Centre for Basic Sciences
Block-JD, Sector-III, Saltlake, Kolkata-700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9331295025 |
| Fax |
|
| Email |
skpal@bose.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Samir Kumar Pal |
| Designation |
Senior Professor |
| Affiliation |
Chemical, Biological and Macromolecular Sciences, S.N.Bose National Centre for Basic Sciences |
| Address |
Room No. 312, Second Floor, Department of Chemical, Biological and Macromolecular Sciences, Experimental Sciences,
S.N.Bose National Centre for Basic Sciences
Block-JD, Sector-III, Saltlake, Kolkata-700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9331295025 |
| Fax |
|
| Email |
skpal@bose.res.in |
|
|
Source of Monetary or Material Support
|
| Nil Ratan Sircar Medical College and Hospital
138, Acharya Jagadish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014
|
|
|
Primary Sponsor
|
| Name |
Prof Asim Kumar Mallick |
| Address |
Nil Ratan Sircar Medical College and Hospital
138, Acharya Jagadish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014
|
| 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 |
| Prof Asim Kumar Mallick |
Nil Ratan Sircar Medical College and Hospital |
Room No. 202, Second Floor, Department of Paediatric Medicine, Neonatal Unit,
Nil Ratan Sircar Medical College and Hospital
138, Acharya Jagadish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014
Kolkata
WEST BENGAL |
9830008057
nrsprojectdrmallick2021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NRS Medical College and Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E806||Other disorders of bilirubin metabolism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manga Nano (Brand Name) or Manganese Citrate (Generic Name) |
The intervention being studied is called Manga Nano (Brand Name) or Manganese Citrate (Generic Name), branded by the company Tridentate Scientific.
Dose: 2 Oral drops once
Duration of therapy: 6 hours |
| Comparator Agent |
Phototherapy or Exchange Transfusion |
The comparator studied for this intervention is phototherapy or exchange transfusion outcomes in human volunteers suffering from neonatal hyperbilirubinemia. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Inclusion criteria comprised of all the neonates irrespective of the gestational age admitted to the Department of Paediatric Medicine, NRSMH with or without jaundice and those requiring phototherapy to monitor the reduction of bilirubin concentration in the blood with response to the phototherapy.
Neonates with neonatal hyperbilirubinemia associated with birth asphyxia. Birth asphyxia is defined if there is presence of at least one of the following condition:
A. Gasping or ineffective breathing or lack of breathing at one minute of life
B. Need for positive pressure Ventilation for >1minute
C. Apgar score <3 at 5 minutes or longer
[according to the definition mentioned in Facility Based Newborn Care by Government of India].
Neonates with neonatal hyperbilirubinemia associated with ABO incompatibility. ABO incompatibility is defined if there was a mismatch between the blood groups of mother and the newborn.
Neonates with neonatal hyperbilirubinemia associated with Rh incompatibility. Rh incompatibility is defined if there was a mismatch between the Rh factors of mother and the newborn.
Neonates with neonatal hyperbilirubinemia associated with G6PD deficiency. G6PD deficiency is defined if G6PD levels in blood was <4.6 U/gm haemoglobin.
|
|
| ExclusionCriteria |
| Details |
Neonates suffering from Sepsis (defined as a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteraemia in the first week of life.); not suffering from neonatal bilirubinemia, and other co-morbities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome Name: Total Serum Bilirubin concentration in blood |
2 hours, 4 hours, 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome Name: Total Serum Bilirubin concentration in blood |
12 hours, 18 hours, 24 hours, 30 hours |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/02/2023 |
| Date of Study Completion (India) |
10/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It has to be noted that in the treatment of neonatal hyperbilirubinemia there are few expensive solutions which is a very hard to make available in a primary healthcare setting. Giving the fact that majority of the Indian population depends on the primary or secondary healthcare setting, proper treatment of neonatal hyperbilirubinemia which is significantly prevalent of our country is limited. The successful outcome of this proposed trial is expected to replace expensive phototherapy and reduce the possibility of exchange even in tertiary health care setting. Low cost of the pharmaceutical intervention is also needed to make the treatment of the prevalent neonatal condition available in primary health care or in fragile point of care settings. The present study examines the efficacy of manganese citrate, a FSSAI approved food supplement which is safe for neonatal subject [FSSAI approved Supplement registered under standards of foods for infant nutrition (Schedule I(a), 11.3) & health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food (Schedule – I B, 8(iii)] to degrade bilirubin during in vivo oral administration in human patients with neonatal hyperbilirubinemia., The purpose of this proof-of-concept trial is to assess the efficacy of manganese citrate along with pharmacokinetics (PK) and pharmacodynamics (PD) of bilirubin by oral administration of manganese citrate in 196 patients with neonatal hyperbilirubinemia A randomized double blinded phototherapy controlled crossover clinical trial to compare the efficacy of Manganese citrate in neonatal hyperbilirubinemia. |