| CTRI Number |
CTRI/2024/11/077173 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development of diagnostic kit for detecting vitamin A deficiency in rural population for primary health centers |
|
Scientific Title of Study
|
Rapid semi-quantitative diagnostic kit for detecting vitamin A deficiency in primary health centers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Upadhya |
| Designation |
Associate Professor and Coordinator |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Molecular Neurosciences Kasturba Medical College Manipal Academy of Higher Education Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8747012060 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Upadhya |
| Designation |
Associate Professor and Coordinator |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Molecular Neurosciences Kasturba Medical College Manipal Academy of Higher Education Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8747012060 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Upadhya |
| Designation |
Associate Professor and Coordinator |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Molecular Neurosciences Kasturba Medical College Manipal Academy of Higher Education Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8747012060 |
| Fax |
|
| Email |
dinesh.upadhya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology Governament of India |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology Governament of India |
| Address |
Department of Biotechnology
6th 8th Floor Block 2 and 4th 5th Floor Block 3 CGO Complex Lodhi Road New Delhi 110 003 India |
| Type of Sponsor |
Government funding agency |
|
|
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 Dinesh Upadhya |
Centre for Molecular Neurosciences |
Centre for Molecular Neurosciences
Room number 01, Floor number 2nd
Department of Anatomy
Kasturba Medical College Manipal Academy of Higher Education Manipal 576104
Udupi
KARNATAKA |
8747012060
dinesh.upadhya@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 Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E50-E64||Other nutritional deficiencies, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Blood samples which are used for diagnostic laboratory tests will be used. |
|
| ExclusionCriteria |
| Details |
Hemolysed or old blood samples |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Defining semi-quantitation values of retinol-binding proteins |
Vitamin A level is measured at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood vitamin A levels in children and adults |
Three years |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
02/12/2024 |
| 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 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
|
According
to WHO, vitamin A deficiency is a major public health problem and its severe
effects are seen in pregnant women and children in low and middle-income
countries. Vitamin A deficiency also contributes to maternal mortality and
other poor outcomes of pregnancy and lactation. Vitamin A-deficient women and
children are highly prone to common infections associated with morbidity and
mortality (WHO database, downloaded on September 5, 2022). Although, from 2010
to 2018, there was a decrease in the cases of vitamin A deficiency in India,
pregnant and lactating women are still at higher risk of vitamin A deficiency
(ICMR 2020 RDA document).
|