Effect of Vitamin B12 oral spray
- Conditions
- VEGETARIAN DIET
- Registration Number
- CTRI/2023/06/054348
- Lead Sponsor
- Dr Nusrat Nabi
- 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 s*econdary objectives are t*o 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 36
•Strictly vegetarian patients •Vitamin B12 deficiency; svB12 <200 pg/mL (148 pmol/L) •Ability to understand and give informed consent.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hamdrad institute of medical science and research
🇮🇳South, DELHI, India
Hamdrad institute of medical science and research🇮🇳South, DELHI, IndiaDR Nusrat NabiPrincipal investigator8953976858nusratnabinaikoo@gmail.com