| CTRI Number |
CTRI/2020/09/028143 [Registered on: 29/09/2020] Trial Registered Prospectively |
| Last Modified On: |
25/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
clinical study to check safety and effectiveness of novel methylcobalamin nasal spray versus oral methylcobalamin in the treatment of subjects with vitamin B12 deficiency |
|
Scientific Title of Study
|
Investigational Products Methylcobalamin (250mcg/spray) nasal spray and Methylcobalamin 1500 mcg oral tablet .Indication Treatment for Vitamin B12 deficiency in consenting adult subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manu Tandon |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroentrology |
| Address |
Asian Institute of Gastroentrology 6-3-661 somajiguda Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
04023378888 |
| Fax |
|
| Email |
mantan_05@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Tandon |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroentrology |
| Address |
Asian Institute of Gastroentrology 6-3-661 somajiguda Hyderabad
TELANGANA
500082
India |
| Phone |
04023378888 |
| Fax |
|
| Email |
mantan_05@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Tandon |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroentrology |
| Address |
Asian Institute of Gastroentrology 6-3-661 somajiguda Hyderabad
TELANGANA
500082
India |
| Phone |
04023378888 |
| Fax |
|
| Email |
mantan_05@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Asian Institute of Gatroentrology |
|
|
Primary Sponsor
|
| Name |
Asian Institute of Gatroentrology |
| Address |
6-3-661 Somajiguda Hyderabad |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Manu Tandon |
Asian Institute of Gastroentrology |
6-3-661 Samajiguda
Hyderabad
TELANGANA |
04023378888
mantan_05@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Asian Institute of Gastroentrology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E539||Vitamin B deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Methylcobalamin Nasal Spray |
Each spray will deliver 0.05 ml of solution containing 250 µg of methylcobalamin
A dose of two nasal-sprays (one spray in each nostril, a total of 500 mcg of Methylcobalamin) on every alternate day for a total of 07 doses |
| Comparator Agent |
Methylcobalamin oral tablets |
Commercially available methylcobalamin oral tablets (1500 mcg).
A single daily dose of 1500 mcg methylcobalamin, shall be consumed for a total of 07 doses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Vitamin B12 level < 200 pg/mL (148 pmol/L)
General Population
Patients who are on Metformin (≥1000mg/day) therapy for ≥ 4 months
Anaemic patients having hemoglobin level of < 9 g/dL
Chronic Alcoholic Patients as per DSM V criteria
Patients on PPI therapy for ≥ 6 months
Patients who have undergone Bariatric Surgery (e.g. RYGB surgery/ Mini gastric bypass surgery/ Sleeve Gastrectomy/ Sleeve Gastroplasty etc) OR Gastric Surgery for any indication.
OR Study population will be any of the following in female population:
Women on Oral Contraceptive Pills
Women with Poly Cystic Ovarian Disease(PCOD) on Metformin
|
|
| 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of change in Vitamin B12 levels on day 7 [i.e. after 03 doses of Nasal B12(Group -A) or 06 doses of oral B12(Group-B) ] |
Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison in change in Vitamin B12 levels on day 7 for Group-B and day 14 for Group-A
Comparison in change in Vitamin B12 levels on day 14 for Group-A and Group-B
Proportion of subjects achieving Vitamin B12 levels ≥ 200 pg/mL on day 7 (Group-B) and on day 14 (Group-A)
Proportion of subjects achieving Vitamin B12 levels ≥ 400 pg/mL on day 7 (Group-B) and on day 14 (Group-A)
Proportion of subjects achieving Vitamin B12 levels ≥ 200pg/mL on day 14 for both the treatment groups
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2020 |
| 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-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, for 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 <200pg/mL and SCCD of Subclinical Cobalamin Deficiency refers to
B12 levels <400pg/mL. 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. It is convenient and painless. Nasal
Methylcobalamin Spray can eliminate the need for 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.
|