clinical study to check safety and effectiveness of novel methylcobalamin nasal spray versus oral methylcobalamin in the treatment of subjects with vitamin B12 deficiency
- Conditions
- Health Condition 1: E539- Vitamin B deficiency, unspecified
- Registration Number
- CTRI/2020/09/028143
- Lead Sponsor
- Asian Institute of Gatroentrology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Vitamin B12 level < 200 pg/mL (148 pmol/L)
General Population
Patients who are on Metformin (>=1000mg/day) therapy for >= 4 months
Anaemic patients having hemoglobin level of < 9 g/dL
Chronic Alcoholic Patients as per DSM V criteria
Patients on PPI therapy for >= 6 months
Patients who have undergone Bariatric Surgery (e.g. RYGB surgery/ Mini gastric bypass surgery/ Sleeve Gastrectomy/ Sleeve Gastroplasty etc) OR Gastric Surgery for any indication.
OR Study population will be any of the following in female population:
Women on Oral Contraceptive Pills
Women with Poly Cystic Ovarian Disease(PCOD) on Metformin
Lactating Women
Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
Patient using any other nasal medication/device.
Patients having a known diagnosis of severe renal impairment or renal failure. Patients on treatment with drugs which interfere with vitamin B12 assay
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method