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Effect of Vitamin B12 oral spray

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054348
Enrollment
36
Registered
2023-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: VIT B12: Vitamin B12 is a nutrient that helps keep your body blood and nerve cells healthy and helps make DNA, the genetic material in all of your cells. Vitamin B12 also helps prevent

Sponsors

Dr Nusrat Nabi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Strictly vegetarian patients •Vitamin B12 deficiency; svB12 •Ability to understand and give informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Nusrat Nabi

hamdard institute of medical science and research

nusratnabinaikoo@gmail.com8953976858

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026