| CTRI Number |
CTRI/2023/07/055208 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary and Lifestyle Modification] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Nutritional Assessment & Intervention through Dietary Counselling with Lifestyle Modification in Vitamin B12 deficient Diabetic Patients its Correlation with Peripheral Neuropathy. |
|
Scientific Title of Study
|
Counselling with Lifestyle Modification in Vitamin B12 deficient Diabetic Patients, its Correlation with Peripheral Neuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jahnvi Sharma |
| Designation |
Research Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Home Science
Vasant Kanya Mahavidyalaya
Kamaccha, BHU
Varanasi
Varanasi
UTTAR PRADESH
221010
India |
| Phone |
9335231524 |
| Fax |
|
| Email |
2107javis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ajai Pandey |
| Designation |
Associate Professor |
| Affiliation |
BHU |
| Address |
Department of Kayachikitsa
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09452827885 |
| Fax |
|
| Email |
drajaipandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Priyanka Kumari |
| Designation |
Assistant Professor |
| Affiliation |
BHU |
| Address |
Department of Home Science
Vasant Kanya Mahavidyalaya
Kamachha, BHU
Varanasi
Varanasi
UTTAR PRADESH
221010
India |
| Phone |
6387502113 |
| Fax |
|
| Email |
priyankahscvkm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa
Institute of Medical Sciences
Banaras Hindu University
Varanasi |
|
|
Primary Sponsor
|
| Name |
Jahnvi Sharma |
| Address |
Vasant Kanya Mahavidyalaya, Kamachha, BHU, Varanasi |
| 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 |
| Jahnvi Sharma |
Institute of Medical Sciences, Banaras Hindu University |
Department of Kayachikitsa
Varanasi
UTTAR PRADESH |
9335231524
2107javis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No Intervention |
| Intervention |
Diet, Lifestyle |
Diet for Vitamin B12 Diabetic Patients and Lifestyle Modifications.
Duration of the Intervention: 2 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with Type 2 Diabetes Mellitus (Age group: 35-75yrs).
2.Patient have Diabetes >6 months.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant, Type1 diabetic patients, Alcoholic.
2.Respondents with lactose intolerance, severe hepatic, renal disorder and other chronic complications.
3.Respondent having any supplement or other experimental medicine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be no significant difference in the severity of peripheral neuropathy after the dietary & lifestyle intervention.
There will be no association of dietary & lifestyle intervention & vitamin B12 serum level of the diabetic Patient. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There will be no correlation of homocysteine level & Vitamin B12 level in blood of the diabetic patient.
There will be no correlation of vitamin B12 level & severity of peripheral neuropathy. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/07/2023 |
| Date of Study Completion (India) |
11/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is undertaken to assess the nutritional status of diabetic patient and intervention for the vitamin b12 deficient patients through diet and modification of lifestyle. Also see the correlation of vitamin b12 level and the peripheral neuropathy. The research design will be Interventional and correlational . Subject will be the diabetic patient from the age group of 35-75 years. The sample size will be 256 Diabetic patients from OPD of Sir Sunderlal Hospital, Varanasi. Data collection of demographic profile, socio economic status and medical history of the respondents. After that anthropometric data (height, weight, BMI) and then data collection of diet intake within 24 hours by 24 hours food recall method. (3 consecutive days). Assessment of Biochemical parameters (FBS, PP, HbA1C, Vit B12, homocysteine level, lipid profile, Hb, MCV) which advise by doctor and examined in pathology in the supervision of doctor. With the help of the screening tool MNSI Questionnaire to evaluation of the severity of peripheral neuropathy of each patient. Analysis of the data before and after 8 weeks follow up.
|