Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: NASO B12 Nasal Spray: One spray containing 250 µg of Methylcobalamin in each nostril (total two sprays containing 500 mcg of Methylcobalamin) will be administered on alternate-day as fo
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either gender in the age group of 18 years and above. 2 Vitamin B12 level less than 200 pg/mL. 3 Willing and able to comply with study requirements, e.g. study drug administration and study visit schedule and willing to fill patient dairy, as indicated by written informed consent provided by the patient. 4 The female subjects who are of non-childbearing potential (or of childbearing potential, and who have a negative urine pregnancy test at screening and willing to maintain reliable birth control throughout the study) and non-lactating
Exclusion criteria
Exclusion criteria: 1 Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication. 2 Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections. 3 Subjects suspected to have illnesses, where Vitamin B12 supplementation is contraindicated. 4 Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure. 5 Patients on treatment with drugs that interfere with Vitamin B12 assay. 6 Patient using any other nasal medication/device. 7 Pregnant and / or Lactating Women 8 Patients having participated in any clinical trial within last 30 days at the time of screening. 9 Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Comparison of change in Vitamin B12 levels on day 1 [i.e. after first dose of Nasal B12 (Test Group) or Sublingual B12 (Reference Group)].Timepoint: on Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of change in Vitamin B12 levels on day 6 [i.e. after 03 doses of Nasal B12 (Test Group) or Sublingual B12 (Reference Group)]. 2. Proportion of subjects achieving Vitamin B12 levels = 400pg/mL on day 1 for both the treatment groups. 3. Proportion of subjects achieving Vitamin B12 levels = 400pg/mL on day 6 for both the treatment groups. Timepoint: On Day 6 | — |
Countries
India
Contacts
Public ContactDr Banshi Saboo
Diabetes Care and Hormone Clinic
Outcome results
None listed