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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  
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 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  
Status 
Not Applicable 
 
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.


 
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