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
|
|
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
|
|
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. |