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CTRI Number  CTRI/2024/04/066019 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare the efficacy and safety of novel Methylcobalamin Spray with Sublingual Methylcobalamin Tablet in treatment of subjects with vitamin B12 deficiency. 
Scientific Title of Study   A Prospective, Open-Label, randomized, Clinical study to compare the efficacy and safety of novel Methylcobalamin Nasal Spray with Sublingual Methylcobalamin Tablet in the treatment of subjects with vitamin B12 deficiency. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DCR/IIS/NASOB12, Version 1.0 dated 29/Feb/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Banshi Saboo 
Designation  Principal Investigator 
Affiliation  Diabetes Care and Hormone Clinic 
Address  1-2 Gandhi park Society, Ground Floor, Near Nehrunagar Cross Road, Ambawadi, Ahmadabad, Gujarat 380015, India

Ahmadabad
GUJARAT
380015
India 
Phone  9824047676  
Fax  -  
Email  banshisaboo@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Banshi Saboo 
Designation  Principal Investigator 
Affiliation  Diabetes Care and Hormone Clinic 
Address  1-2 Gandhi park Society, Ground Floor, Near Nehrunagar Cross Road, Ambawadi, Ahmadabad, Gujarat 380015, India

Ahmadabad
GUJARAT
380015
India 
Phone  9824047676  
Fax  -  
Email  banshisaboo@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Banshi Saboo 
Designation  Principal Investigator 
Affiliation  Diabetes Care and Hormone Clinic 
Address  1-2 Gandhi park Society, Ground Floor, Near Nehrunagar Cross Road, Ambawadi, Ahmadabad, Gujarat 380015, India

Ahmadabad
GUJARAT
380015
India 
Phone  9824047676  
Fax  -  
Email  banshisaboo@hotmail.com  
 
Source of Monetary or Material Support  
Troikaa Pharmaceuticals Limited, Troikaa House, Satya Marg, Bodakdev, Ahmedabad, Gujarat 380054, India 
 
Primary Sponsor  
Name  Troikaa Pharmaceuticals Limited 
Address  Troikaa House Satya Marg Bodakdev Ahmedabad Gujarat 380054 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Banshi Saboo  Dia Care Research  1-2 Gandhi park Society, Ground Floor, Near Nehrunagar Cross Road, Ambawadi, Ahmadabad, Gujarat 380015, India
Ahmadabad
GUJARAT 		 9824047676

banshisaboo@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Aatman Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NASO B12 Nasal Spray  One spray containing 250 µg of Methylcobalamin in each nostril (total two sprays containing 500 mcg of Methylcobalamin) will be administered on alternate-day as follows on Day 1, 3 and 5. 
Comparator Agent  Sublingual Methylcobalamin Tablets  Sublingual tablet containing Vitamin B12 1500 µg on day 1, 3 and 5. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Patients of either gender in the age group of 18 years and above.
2 Vitamin B12 level less than 200 pg/mL.
3 Willing and able to comply with study requirements, e.g. study drug administration and study visit schedule and willing to fill patient dairy, as indicated by written informed consent provided by the patient.
4 The female subjects who are of non-childbearing potential (or of childbearing potential, and who have a negative urine pregnancy test at screening and willing to maintain reliable birth control throughout the study) and non-lactating  
 
ExclusionCriteria 
Details  1 Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
2 Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
3 Subjects suspected to have illnesses, where Vitamin B12 supplementation is contraindicated.
4 Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure.
5 Patients on treatment with drugs that interfere with Vitamin B12 assay.
6 Patient using any other nasal medication/device.
7 Pregnant and / or Lactating Women
8 Patients having participated in any clinical trial within last 30 days at the time of screening.
9 Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Comparison of change in Vitamin B12 levels on day 1 [i.e. after first dose of Nasal B12 (Test Group) or Sublingual B12 (Reference Group)].  on Day 1 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of change in Vitamin B12 levels on day 6 [i.e. after 03 doses of Nasal B12 (Test Group) or Sublingual B12 (Reference Group)].
2. Proportion of subjects achieving Vitamin B12 levels ≥ 400pg/mL on day 1 for both the treatment groups.
3. Proportion of subjects achieving Vitamin B12 levels ≥ 400pg/mL on day 6 for both the treatment groups.
 		 On Day 6 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/04/2024 
Date of Study Completion (India) 03/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
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 clinical trial is a prospective, open label, randomized, clinical study to compare the efficacy and safety. A total 30 Male and Female subjects, whose Vitamin B12 level is <200pg/mL will be enrolled.

Subject will be screened according to the study inclusion and exclusion criteria within 2 weeks prior to randomization (Day 0). Subject meeting all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. Subjects who provide informed consent to participate in the study will  be randomized either to the Methylcobalamin NASO B12 Spray or Sublingual Methylcobalamin Tablet in a 1:1 ratio. Each group will consist of 15 randomized subjects. 
 
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