A study to evaluate the efficacy and safety of oral spray formulation of Vitamin B12: A pilot study

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.