A prospective, open-label, randomized, comparative clinical trial to assess theefficacy and safety of a novel Methylcobalamin Nasal Spray (NASO B12) or oral B12 supplementation in the treatment of subjects with vitamin B12 deficiencyas well as to evaluate the duration of efficacy

This will be a prospective, randomized, open-label, comparative clinical study. 50 patients having vitamin B12 deficiency will be enrolled in this study. Enrolled patients will be randomized in 2 groups in 1:1 ratio as per reandomizationto receive either the novel methylcobalamin nasal spray (test group) or oral supplement (reference group). According to randomization, patients of test group will receive a novel Methylcobalamin nasal spray 250 µg/spray “NASO B12” and reference group II patient will receive Oral B12 tablets. Patients of both the groups will receive either novel Methylcobalamine nasal spray or oral B12on day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21 (on alternate days for total 11 days). After treatment, each patient will be followed up till week 15(12 weeks after treatment period) or Vitamin B12 level reach < 200 pg/mL; whichever earlier.

 As this study is IIS (Investigator Inititated Study), no regulatory approval is required to initiate the study. The study will be initiated only after getting approval from Independent/Institutional ethics committee. The study will be carried out according to the protocol approved by the IEC/IRB of the participating institution in accordance with Declaration of Helsinki (Brazil, October 2013) and as per the New Drugs and Clinical Trial Rules, 2019, Ethical guidelines for biomedical research on human participants, ICMR (Indian Council of Medical Research (2006)] and ICH (International Conference on Harmonization) E6 ‘Guideline for Good Clinical Practice- Consolidated Guidance for Industry’.