| CTRI Number |
CTRI/2024/09/073553 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Thiamine Deficiency in Infants Through Blood Sample Examination Using Light. |
|
Scientific Title of Study
|
Study of Thiamine Deficiency in Infants by Analysing Blood Sample Using Spectroscopic Technique |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Clint Mathew |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics
LG-01, AB-5, MIT,
Manipal Academy of Higher Education
Manipal, Karnataka, India-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8281565126 |
| Fax |
|
| Email |
clint.mathew@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Clint Mathew |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics
LG-01, AB-5, MIT,
Manipal Academy of Higher Education
Manipal, Karnataka, India-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8281565126 |
| Fax |
|
| Email |
clint.mathew@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Clint Mathew |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Atomic and Molecular Physics
LG-01, AB-5, MIT,
Manipal Academy of Higher Education
Manipal, Karnataka, India-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8281565126 |
| Fax |
|
| Email |
clint.mathew@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka-576104 |
| Type of Sponsor |
Research institution |
|
|
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 Leslie Edward S Lewis |
Kasturba Medical College |
First Floor, Department of Pediatrics, Women and Children Block, Manipal- 576104
Udupi
KARNATAKA |
9449208476
leslie.lewis@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy infants who undergo routine blood test |
| Patients |
(1) ICD-10 Condition: E519||Thiamine deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Control-Left over blood samples will be collected from healthy infants aged 1 month to 1 year.
Case- Left over blood samples will be collected from infants presenting with respiratory diseases, ranging in age from 1 month to 1 year. |
|
| ExclusionCriteria |
| Details |
Control- All participants above 1 year old and having any health issues are excluded.
Case- All participants above 1 year old are excluded. Babies with sepsis are also excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome might help to detect thiamine deficiency in infants. |
2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A cost-effective method for the detection of thiamine deficiency in infants. |
3 years. |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
25/09/2024 |
| 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="3"
Months="0"
Days="0" |
|
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
|
The gold standard method for detecting Thiamine deficiency is Liquid Chromatography-Mass Spectrometry (LC-MS), which is expensive and time consuming. So we are developing a technique based on HPLC combined with LED induced fluorescence for the detection of Thiamine deficiency in infants. The left over blood samples will be used for this study. Deficiency of thiamine can lead to lactic acidosis, which causes respiratory problem. So, we will be collecting blood sample from infants presenting with respiratory diseases as case. The Raman spectra of infantile blood will be recorded using the custom-built micro-Raman spectrometer for the comparison. |