CTRI Number |
CTRI/2023/06/054348 [Registered on: 22/06/2023] Trial Registered Prospectively |
Last Modified On: |
19/05/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical |
Study Design |
Single Arm Study |
Public Title of Study
|
Effect of Vitamin B12 oral spray |
Scientific Title of Study
|
A study to evaluate the efficacy and safety of oral spray formulation of Vitamin B12: A pilot study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nusrat Nabi |
Designation |
Assistant Professor |
Affiliation |
hamdard institute of medical science and research |
Address |
room no 235,2nd floor, department of pharmacology, Hamdard Nagar, Guru Ravidas Marg, Hamdard Nagar, New Delhi, Delhi 110062 South DELHI 110062 India |
Phone |
8953976858 |
Fax |
|
Email |
nusratnabinaikoo@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nusrat Nabi |
Designation |
Assistant Professor |
Affiliation |
hamdard institute of medical science and research |
Address |
room no 235,2nd floor, department of pharmacology, Hamdard Nagar, Guru Ravidas Marg, Hamdard Nagar, New Delhi, Delhi 110062
DELHI 110062 India |
Phone |
8953976858 |
Fax |
|
Email |
nusratnabinaikoo@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nusrat Nabi |
Designation |
Assistant Professor |
Affiliation |
hamdard institute of medical science and research |
Address |
room no 235,2nd floor, department of pharmacology, Hamdard Nagar, Guru Ravidas Marg, Hamdard Nagar, New Delhi, Delhi 110062
DELHI 110062 India |
Phone |
8953976858 |
Fax |
|
Email |
nusratnabinaikoo@gmail.com |
|
Source of Monetary or Material Support
|
Hamdard institute of medical sciences and research and associated HAHC hospital, New Delhi |
|
Primary Sponsor
|
Name |
Dr Nusrat Nabi |
Address |
room no 235,second floor, department of pharmacology, HIMSR |
Type of Sponsor |
Private medical college |
|
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 Nusrat Nabi |
Hamdrad institute of medical science and research |
HAHC HOSPITAL,Hamdard Nagar, Guru Ravidas Marg, Hamdard Nagar, New Delhi, Delhi 110062 South DELHI |
8953976858
nusratnabinaikoo@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
HIMSR IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
VEGETARIAN DIET |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
VITAMNIN B12 |
Vitamin B12 is a nutrient that helps keep your bodys blood and nerve cells healthy and helps make DNA, the genetic material in all of your cells. Vitamin B12 also helps prevent megaloblastic anemia.
Dose: one serving daily
One serving: 4 oral sprays
Vit B12 per serving: 1500mcg
Product: Imbisem marketed by Semitic Lab.Pvt. Ltd.( manufactered by Walpur nutri science pvt ltd)
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
•Strictly vegetarian patients
•Vitamin B12 deficiency; svB12 <200 pg/mL (148 pmol/L)
•Ability to understand and give informed consent
|
|
ExclusionCriteria |
Details |
1.Oral submucosal fibrosis
2.Oral leukoplakia
3.Pregnant or breastfeeding
4.Prior treatment with Vitamin B12 supplementation (last 1 month)
5.Any other medical condition that would make participation in the study unsafe or unlikely to yield valid results
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
will comprise of the percentage of patients achieving svB12 levels 200 pg/mL (148 pmol/L), 20% increase and 50pg/mL increase, at 3 and 6 weeks of treatment with Vitamin B12 oral spray as well as the incidence of adverse events experienced during the treatment period. |
3weeks&6weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
will include serum Vitamin B12 levels, hemoglobin, hematocrit, and red blood cell count and MCV at baseline, 3 weeks and 6 weeks of treatment |
3weeks&6weeks |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
01/05/2024 |
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
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Background & Objectives: This is a pilot study aimed to evaluate the safety and efficacy profile of vitamin B12 oral spray (Imbisem), a food supplement, in patient with Vitamin B12 deficiency, with primary objectives to evaluate the proportion of patients achieving svB12 levels >200 pg/mL (148 pmol/L) at 3 and 6 weeks of treatment with Vitamin B12 oral spray and to analyze the incidence of adverse events experience during the treatment period. The secondary objectives are to determine the Vitamin B12 levels at baseline, 3 weeks and 6 weeks of treatment, to determine the percentage change in Vitamin B12 levels from baseline, to determine proportion of patients achieving 20% increase and an absolute increase of 50 pg/mL at 3 and 6 weeks and to compare the hemoglobin and Mean Corpuscular Value (MCV) with baseline. Material & Methods: This pilot study is planned to be a prospective, open-label study, conducted in accordance with the GCP-ICH guidelines as well as revised GCP guidelines by CDSCO. The study will commence after due approval by the Institutional Ethics committee with a sample size of 36 patients to obtain preliminary data for further designing a randomized controlled trail. The study will enroll 36 strictly vegetarian adults aged between 18-65 years, with vitamin B12 deficiency having Vitamin B12 levels <200 pg/mL (148 pmol/L). Participants will be recruited from the Medicine out-patient clinic of HAHC Hospital. Participants taking any supplements at the time of enrolment (for last 1 month) will be instructed to cease the supplements one week prior to participation in the study. Written informed consent will be obtained from each participant before enrollment in the study. |