Effect of Vitamin B12 oral spray
Not Applicable
- Registration Number
- CTRI/2023/06/054348
- Lead Sponsor
- Dr Nusrat Nabi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Strictly vegetarian patients
•Vitamin B12 deficiency; svB12 <200 pg/mL (148 pmol/L)
•Ability to understand and give informed consent
Exclusion Criteria
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.Timepoint: 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 treatmentTimepoint: 3weeks&6weeks