FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/044647 [Registered on: 04/08/2022] Trial Registered Prospectively
Last Modified On: 02/08/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Measurement of normal vitamin B1 level in babies 
Scientific Title of Study   Establishment of a Bioanalytical Method and Reference Range for Thiamine Levels in Infants 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ysphaneendramallimoggala 
Designation  Research Scholar 
Affiliation  KASTURBA MEDICAL COLLEGE MANIPAL 
Address  DEPARTMENT OF PAEDIATRICS KASTURBA MEDICAL COLLEGE MANIPAL

Udupi
KARNATAKA
576104
India 
Phone  9844318736  
Fax    
Email  moggala.y@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Leslie Edward S Lewis 
Designation  Professor and Head 
Affiliation  KASTURBA MEDICAL COLLEGE MANIPAL 
Address  DEPARTMENT OF PAEDIATRICS KASTURBA MEDICAL COLLEGE MANIPAL

Udupi
KARNATAKA
576104
India 
Phone  9449208476  
Fax    
Email  leslie.lewis@manipal.edu  
 
Details of Contact Person
Public Query  
Name  ysphaneendramallimoggala 
Designation  Research Scholar 
Affiliation  KASTURBA MEDICAL COLLEGE MANIPAL 
Address  DEPARTMENT OF PAEDIATRICS KASTURBA MEDICAL COLLEGE MANIPAL


KARNATAKA
576104
India 
Phone  9844318736  
Fax    
Email  moggala.y@learner.manipal.edu  
 
Source of Monetary or Material Support  
MANIPAL ACADEMY OF HIGHER EDUCATION MANIPAL 
Vision Group on Science and Technology VGST 
 
Primary Sponsor  
Name  MAHE 
Address  Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Vision Group on Science and TechnologyVGST  7th Floor, 4th Gate, M.S. Building, Dr. Ambedkar Veedhi, Bengaluru, Karnataka 560001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
YSPHANEENDRAMALLIMOGGALA  KASTURBA MEDICAL COLLEGE MANIPAL  DEPARTMENT OF PEADIATRICS KASTURBA MEDICAL COLLEGE MANIPAL
Udupi
KARNATAKA 		 9844318736

moggala.y@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy newborns and infants 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  6.00 Month(s)
Gender  Both 
Details  Healthy newborns and infants 
 
ExclusionCriteria 
Details  Premature Participants, Participants who have been on thiamine supplementation, Participants with pre-existing Liver/Renal/Cardiac/Neurological disorders, Participants on steroids, Participants diagnosed with any congenital disorder, including metabolic/ genetic/ endocrine disorders, Babies on formula feeds, Babies on any medications except Vitamin D supplements, Incomplete case records, Participants not willing to participate

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Estimating of thiamine levels in apparently healthy newborns and infants to establish a reference range  At the time of collection  
 
Secondary Outcome  
Outcome  TimePoints 
To assess thiamine deficiency in sick babies  At the time of collection 
 
Target Sample Size   Total Sample Size="362"
Sample Size from India="362" 
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)   20/08/2022 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The epidemiology of treatable thiamine deficiency in the Indian scenario remains unknown the paucity of Indian studies on native thiamine reference range studies available for the thiamine reference range. It is believed that exclusively breastfed infants of lactating Indian mothers (characteristic locally prevalent dietary restrictions) are prone to thiamine deficiency. These infants present with irritability, failure to thrive, seizures, respiratory distress, unexplained severe metabolic acidosis, and severe forms presence of stress factors, leading to unexplained sudden infantile death.

 This study aims to present the epidemiology of infantile thiamine deficiency (prenatal, at birth and postnatal) in the Udupi district.

 Need for the study: Limited analytical method to estimate TDP levels using HPLC. The reported methods use LC-MS/MS which are not affordable in all laboratories.

Objective 1: Development of a bioanalytical method for determining Thiamine levels in Blood and DBS by HPLC

 Sample Preparation for the establishment of reference ranges/ estimation of thiamine levels:

 

Ø  The whole blood will be lysed with the suitable organic solvent, and the sample will be cleaned by protein precipitation.

 

Ø  The DBS samples will be extracted with the suitable solvent to achieve the maximum recovery with acceptable precision.

 

Ø  The extract will be centrifuged, processed and injected after a suitable dilution for both whole bold and DBS sample.

 

Ø  Thiamine levels will be quantified using HPLC method.

 

Ø  Reference range will be proposed based on statistical analysis & findings.


Proposed HPLC Method for thiamine estimation in Blood & DBS:

 

·         Equipment: Shimadzu LC 2030 with UV and FLD detector

 

·         Column: Agilent SB C18 (250 X 4.6 mm, 5 µm) or any suitable equivalent column.

·         Mobile phase: pH 2.1 10mM Na2HPO4 buffer with suitable ion-pairing reagent and Methanol (9:1).

·         Calibration Standards: Sufficient concentration of standard thiamine diphosphate stock solution will be spiked into the whole blood and processed for analysis to get linearity range 1 ng/ml to 500 ng/ml. For DBS, spiked blood will be applied in the suitable DBS card.

·         Chromatographic conditions: The Flow rate, injection volume, column temperature, sample preparation, mobile phase composition will be optimized during the development with UV-detector.

·         Linearity, limit of detection, imprecision, accuracy, and interference will be determined for the optimized method. 

Objective 2:

 Healthy Neonatal participants will be recruited after obtaining informed consent from parents/guardians.

 

Neonatal blood sample:

·         0.5 ml blood will be collected from the participant when blood is collected for other routine laboratory investigations

·         Leftover blood will be collected from the biochemistry department.

·         Dried Blood Samples will be collected during New-born Screening Sampling. (In case only whole blood sample is available for a participant, the investigator will prepare a dried blood spot sample using the available whole blood itself and no additional samples will be collected from the study participants 

·         Collected samples will be appropriately labelled and stored in -80ºC bio freezer until the day of analysis.

 

Blood sample from infants:

·         0.5 ml blood will be collected from the participant when blood is collected for other routine laboratory investigations

·         Leftover blood will be collected from the biochemistry department.

·         Dried Blood Samples will be prepared from whole blood samples (No additional samples will be collected from the study participants)

·         Collected samples will be appropriately labelled and stored in -80ºC bio freezer until the day of analysis.

Sample Preparation for the establishment of reference ranges/ estimation of  thiamine levels:

Ø  The whole blood will be lysed with the suitable organic solvent, and the sample will be cleaned by protein precipitation.

Ø  The DBS samples will be extracted with the suitable solvent to achieve the maximum recovery with acceptable precision.

Ø  The extract will be centrifuged, processed and injected after a suitable dilution for both whole bold and DBS sample

Ø  Thiamine levels will be quantified using HPLC method.

Ø  Reference range will be proposed based on statistical analysis & findings.

Outcome measures :

1.    Develop a budget-friendly, rapid, reliable, sensitive, validated, and feasible screening method to detect neonatal thiamine deficiency.

 2. Establishment of a neonatal and infantile thiamine reference range, thereby facilitating screening, diagnosis, and early correction of thiamine deficiency and its associated morbidities in infants. 


 
Close