Health Condition 1: null- Vitamin B12 deficiency
Conditions
Interventions
Intervention1: Methylcobalamin Nasal Spray 250 mcg per puff: Treatment phase: 1 puff in each nostril, total two puffs at a time on alternate days for 2 weeks e.g. 7 doses.
Maintenance phase: 1 puff in
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex in the age group of 18-55 years 2. Patients with serum vitamin B12 levels less than 200 pg/ml at the time of screening. 3. Patients willing to give written informed consent prior to participation in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity or allergies to cobalt and/or Vitamin B12 or any component of the medication. 2. Patients with serum folate 3. Patient with severe anaemia defined as Haemoglobin 4. Patients with history of or diagnosed with thrombocytopenia, leucopenia, pancytopenia or any other haematological malignancy. 5. Patients with history of recurrent or current abuse of alcohol 6. Patients with signs or symptoms of neurological involvement. 7. Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections. 8. Patient using any transnasal/ intranasal medication. 9. Patients having renal insufficiency. (serum creatinine > 1.2 mg/dl) 10. Patients on treatment with drugs which interfere with folate metabolism or interfere with folic acid and vitamin B12 assay. 11. Female patients who are pregnant or planning to conceive or nursing 12. Patient has participated in another clinical study (investigational or marketed product) within 30 days prior to screening. 13. Patients having any other clinically significant systemic condition that is life threatening, or in the opinion of the investigator, does not justify their inclusion in the study. 14. Patient not having facility for telephonic communication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients achieving vitamin B12 levels greater than 200pg/ml 2) Proportion of patients maintaining their vitamin B12 level greater than 200pg/mlTimepoint: 1) End of 2 weeks 2) End of 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Vitamin B12 levels as compared to baseline vitamin B12 levels. 2) Vitamin B12 levels as compared to vitamin B12 levels at end of 2 weeks. 3) Serum methylcobalamin levels as compared to baseline. 4) Hemoglobin values as compared to baseline. 5) Physicianâ??s global assessment 6) Treatment emergent adverse events â?? incidence and severity 7) Abnormality in vital signs and physical examination 8) Global tolerability at end of studyTimepoint: 1) At end of 1st and 2nd week 2) at end of 4th and 6th week 3) at week 2 and 6 4) at week 1, 2, 4 and 6 5) at end of treatment 6) Throughout the study 7) Throughout the study 8) End of treatment | — |
Countries
India
Contacts
Public ContactDr Amarinder Singh
Troikaa Pharmaceuticals Limited
Outcome results
None listed