| CTRI Number |
CTRI/2025/06/088083 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to test how safe and effective a new vitamin B12 nasal spray (called NASO B12) is for treating vitamin B12 deficiency in people with type 2 diabetes who are taking the medicine metformin. |
|
Scientific Title of Study
|
A Prospective, Open-Label, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of a Novel Methylcobalamin Nasal Spray (NASO B12) in the Treatment of Vitamin B12 Deficiency in Type II Diabetes Mellitus Patients Receiving Metformin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRPL-NASO-01-2025, Version 01, Date 05 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayur Agrawal |
| Designation |
Medical Director and Consultant Endocrinologist |
| Affiliation |
Hormone India Diabetes & Endocrine Centre |
| Address |
Room no. 01, Ground Floor, E4/323, Behind 10 No. Parking, Arera Colony
Bhopal
MADHYA PRADESH
462016
India |
| Phone |
8989893232 |
| Fax |
|
| Email |
mayuragrawal2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayur Agrawal |
| Designation |
Medical Director and Consultant Endocrinologist |
| Affiliation |
Hormone India Diabetes & Endocrine Centre |
| Address |
Room no. 01, Ground Floor, E4/323, Behind 10 No. Parking, Arera Colony
Bhopal
MADHYA PRADESH
462016
India |
| Phone |
8989893232 |
| Fax |
|
| Email |
mayuragrawal2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukul Maurya |
| Designation |
Director & Founder |
| Affiliation |
ProClin Research Pvt Ltd |
| Address |
Room no. 01, 2nd Floor, Plot 01, Near Nevri Mandir, Gufa Mandir Road, Lalghati
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7032802286 |
| Fax |
|
| Email |
mukul@proclinresearch.com |
|
|
Source of Monetary or Material Support
|
| Hormone India Diabetes & Endocrine Centre, E4/323, Behind 10 No. Parking, Arera Colony, Bhopal, M.P. – 462016, India. |
|
|
Primary Sponsor
|
| Name |
Dr Mayur Agrawal |
| Address |
Room 01, Ground Floor, Hormone India Diabetes & Endocrine Centre, E4/323, Behind 10 No. Parking, Arera Colony, Bhopal, M.P. – 462016, India. |
| 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 |
| Dr Mayur Agrawal |
Hormone India Diabetes & Endocrine Centre |
Room 01, Ground Floor, E4/323, Behind 10 No. Parking, Arera Colony, Bhopal
Bhopal
MADHYA PRADESH |
8989893232
mayuragrawal2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Charak Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Methylcobalamin nasal spray NASO B12 |
Each spray will deliver 0.05 ml of a solution containing 250 micro g of methylcobalamin. Treatment Phase 1 puff in each nostril, total two puffs at a time on alternate days for 39
days (20 doses) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Type II Diabetic Mellitus patients who are on Metformin (more than and equal to 1000mg/day) therapy since more than or equal to 4 months.
2. Vitamin B12 level more than 200 pg/mL (148 pmol/L)
3. Willing & able to comply with study requirements, e.g. usage of medicines as per protocol, willing to adhere to study visit schedule, and willing to fill Patient Diary, as indicated by written informed consent provided by the patient.
4. If women of childbearing potential are recruited they must be non-pregnant (supported by a negative urine pregnancy test at screening), and be willing to maintain reliable birth control throughout the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or Lactating Women
2. Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
3. Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies, or upper respiratory tract infections.
4. Patient using any other nasal medication/device.
5. Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure.
6. Patients on treatment with drugs that interfere with vitamin B12 assay.
7. Participated in any clinical trial within the last 30 days at the time of screening.
8. Any disorder or condition that in the opinion of the investigator would prohibit study participation or affect the study outcome. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Vitamin B12 level between baseline to various time-points |
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To record the duration of time the serum Vitamin B12 level remained more than and equal to 400 pg/mL after last dose
2. To record the duration of time the serum Vitamin B12 level remained more than or equal to 200 pg/mL after last dose.
3. Occurrence of any local or systemic adverse event. |
10 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/06/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Vitamin B12, also known as cobalamin, anti-pernicious anaemia factor, Castle’s extrinsic factor, or animal protein factor is the largest and most complex of all the vitamins. It is necessary for the formation of blood cells, nerve sheaths, and various proteins. It is also involved in fat and carbohydrate metabolism. It is also essential for DNA synthesis, cellular energy production, and growth. Vitamin B12 is also required in the synthesis of folate polyglutamates (active coenzymes required in the formation of nerve tissue) and in the regeneration of folic acid during red blood cell formation. Cobalamin Deficiency is defined as B12 levels less than 200pg/mL and SCCD or Subclinical Cobalamin Deficiency refers to B12 levels less than 400pg/mL. Evidence indicates methylcobalamin is utilized more efficiently than cyanocobalamin to increase levels of one of the coenzyme forms of vitamin B12. Experiments have shown similar absorption of methylcobalamin & cyanocobalamin following oral administration. Also, the quantity of cobalamin detected following a small oral dose of methylcobalamin is similar to the amount following administration of cyanocobalamin; but significantly more cobalamin accumulates in liver tissue following administration of methylcobalamin. Human urinary excretion of methylcobalamin is about one-third that of a similar dose of cyanocobalamin, indicating substantially greater tissue retention. Thus, methylcobalamin has greater utility over cyanocobalamin. Nasal Methylcobalamin therapy has been introduced as an innovative route for the systemic availability of B12 due to the large surface area, porous endothelial membrane, high total blood flow, the avoidance of first-pass metabolism, and ready accessibility of the route. Methylcobalamin is absorbed rapidly, safely, and consistently from the nasal cavity after intranasal administration. Further, the intranasal formulation has overcome the drawbacks of the intramuscular formulation. It is convenient and painless. Nasal Methylcobalamin Spray can eliminate the need for the assistance of Nursing staff or Paramedics for injection and reduce the overall cost of therapy. It would also facilitate ease of administration and improve compliance. |