| CTRI Number |
CTRI/2022/08/044754 [Registered on: 18/08/2022] Trial Registered Prospectively |
| Last Modified On: |
11/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of vitamin B 12 deficiency in adult subjects by using Methylcobalamin (250 µg/Spray) nasal spray |
|
Scientific Title of Study
|
A prospective, open-label, single-arm clinical study to evaluate the safety and
effectiveness of novel Methylcobalamin nasal spray in the treatment of subjects with
vitamin B 12 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 Banshi Saboo |
| Designation |
Principal Investigator |
| Affiliation |
Dia Care Research, |
| Address |
Dia Care Research
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad
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 |
Dia Care Research, |
| Address |
Dia Care Research
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad
GUJARAT
380015
India |
| Phone |
9824047676 |
| Fax |
|
| Email |
banshisaboo@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Banshi Saboo |
| Designation |
Principal Investigator |
| Affiliation |
Dia Care Research, |
| Address |
Dia Care Research
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad
GUJARAT
380015
India |
| Phone |
9824047676 |
| Fax |
|
| Email |
banshisaboo@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dia Care Research
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Dr Banshi Saboo |
| Address |
Dia Care Research
Gandhi Park
Near Nehru nagar Cross Road
Ambawadi
Ahmedabad |
| 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 Banshi Saboo |
Dia Care Research |
Room Number 5, Research Department,
Gandhi Park,
Near Nehru nagar Cross Road
Ambawadi
Ahmadabad
GUJARAT |
9824047676
banshisaboo@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shrey Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D519||Vitamin B12 deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Vitamin B12 level < 200 pg/mL (148 pmol/L)
2) Above the age of 18 years
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) Lactating Women
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) Patient using any other nasal medication/device.
4) Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic
failure.
Patients on treatment with drugs that interfere with vitamin B12 assay.
5) Participated in any clinical trial within the last 30 days at the time of screening.
6) 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
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Vitamin B 12 levels on day 8 from Baseline [i.e. after 07 doses of Nasal
B 12 ]
2. Change in Vitamin B 12 levels on day 14 from Baseline [i.e. after 14 doses of Nasal
B 12 ] |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The proportion of subjects achieving Vitamin B12 levels ≥ 200 pg/mL on day 8.
2. The proportion of subjects achieving Vitamin B12 levels ≥ 400 pg/mL on day 8
3. The proportion of subjects achieving Vitamin B12 levels ≥ 200pg/mL on day 14
4. The proportion of subjects achieving Vitamin B12 levels ≥ 400pg/mL on day 14 |
15 days |
|
|
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)
|
24/08/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
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 <200pg/mL and SCCD or 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, 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.The aim of study is to evaluate the safety and effectiveness of novel methylcobalamin nasal
spray in the treatment of subjects with vitamin B12 deficiency. the primary end points are to Change in Vitamin B12 levels on day 8 from Baseline [i.e. after 07 doses of Nasal
B12] and Change in Vitamin B12 levels on day 14 from Baseline [i.e. after 14 doses of Nasal
B12]. |