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CTRI Number  CTRI/2020/08/027422 [Registered on: 27/08/2020] Trial Registered Prospectively
Last Modified On: 19/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To check the effectiveness and safety of Methylcobalamin nasal spray in comparison with oral methylcobalamin tablet and methylcobalamin injection. 
Scientific Title of Study   A prospective, randomized, open label, clinical study to evaluate safety and effectiveness of novel methylcobalamin nasal spray compared to oral methylcobalamin in the treatment of vitamin B12 deficiency. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dushyant Balat 
Designation  Principal Investigator 
Affiliation  Apollo Hospitals International Ltd Gandhinagar 
Address  Apollo Hospitals International Ltd Gandhinagar

Gandhinagar
GUJARAT
382424
India 
Phone  9825015055  
Fax    
Email  drdushyant.balat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dushyant Balat 
Designation  Principal Investigator 
Affiliation  Apollo Hospitals International Ltd Gandhinagar 
Address  Apollo Hospitals International Ltd Gandhinagar

Gandhinagar
GUJARAT
382424
India 
Phone  9825015055  
Fax    
Email  drdushyant.balat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dushyant Balat 
Designation  Principal Investigator 
Affiliation  Apollo Hospitals International Ltd Gandhinagar 
Address  Apollo Hospitals International Ltd Gandhinagar

Gandhinagar
GUJARAT
382424
India 
Phone  9825015055  
Fax    
Email  drdushyant.balat@gmail.com  
 
Source of Monetary or Material Support  
Apollo Hospitals International Ltd., Plot no 1A, Bhat GIDC Estate, gandhinagar, Gujarat - 382428 
 
Primary Sponsor  
Name  Dr Dushyant Balat 
Address  Apollo Hospitals International Ltd., Plot no 1A, Bhat GIDC Estate, gandhinagar, Gujarat - 382428 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dushyant Balat  Apollo Hospitals International Ltd  Ground floor, health checkup department, Plot No.1A, Gandhinagar - Ahmedabad Road Bhat, GIDC Bhat,
Gandhinagar
GUJARAT 
9825015055

drdushyant.balat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E538||Deficiency of other specified B group vitamins,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Methycobalamin Intramuscular Injection   500 mcg of methylcobalamin intramuscular injection every alternate day for 15 days. 
Intervention  Methylcobalamin Nasal Spray  Total dose of 500 mcg of Methylcobalamin Nasal Spray, 250 mcg in each dose/spray on every alternate day for 15 days 
Comparator Agent  Methylcobalamin Oral Tablet  1500 mcg of dose of oral methylcobalamin tablet once a day for 7 days during the study period of 15 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients meeting all of the following will be included in the study:
Vitamin B12 level < 200 pg/mL (148 pmol/L)
Willing & able to comply with study requirements, e.g. usage of medicines as per protocol, willing to adhere with study visit schedule and willing to fill Patient Diary, as indicated by written informed consent provided by the patient.
If women of childbearing potential are recruited they must be non-pregnant (supported by negative urine pregnancy test at screening), and be willing to maintain reliable birth control throughout the study.
 
 
ExclusionCriteria 
Details  Lactating Women
Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
Patient using any other nasal medication/device.
Patients having a known diagnosis of severe renal impairment or renal failure. Patients on treatment with drugs which interfere with vitamin B12 assay.
Participated in any clinical trial within last 30 days at the time of screening.
Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of change in Vitamin B12 levels on day 7 of Nasal B12(Group -A), oral B12(Group-B) and Intramuscular B12 Injection (Group-C) ]  Day 7 and day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of subjects achieving Vitamin B12 levels ≥ 200 pg/mL and ≥ 400 pg/mL on day 7 and on day 14   Day 7 and day 14  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   27/08/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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, antipernicious - anemia 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, for cellular energy production and growth. Vitamin B12 is also required in the synthesis of folate polyglutamates (active co-enzymes required in the formation of nerve tissue) and in the regeneration of folic acid during red blood cell formation. Evidence indicates methylcobalamin is utilized more efficiently than cyanocobalaminto 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. The treatment of choice for cobalamin deficiency has been the administration of cobalamin by intramuscular injections. In case of oral supplementation, approximately only 1% of ingested B12 is absorbed via the gastrointestinal tract requiring IF factor and other transport proteins for proper absorption. So requirement of high doses and co transporters limit the use of oral cobalamin form. Nasal Methylcobalamin therapy has been recently 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, intranasal formulation has overcome the drawbacks of intramuscular formulation.

 
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