to compare the effectiveness of Methylcobalamin Nasal Spray and Oral Methylcobalamin tablet in B12 deficient patients.

Phase 4

• Conditions: Health Condition 1: E53- Deficiency of other B group vitamins

• Registration Number: CTRI/2020/03/023938
• Lead Sponsor: Dr Arunansu Talukdar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Vitamin B12 level < 200 pg/mL (148 pmol/L)

Above the age of 18 years

Willing & able to comply with study requirements, e.g. usage of medicines as per protocol, willing to adhere with study visit schedule and willing to fill Patient Diary, as indicated by written informed consent provided by the patient.

Study population will be EITHER any of the following in either gender:

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

If women of childbearing potential are recruited they must be non-pregnant (supported by negative urine pregnancy test at screening), and be willing to maintain reliable birth control throughout the study.

Exclusion Criteria

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.

Participated in any clinical trial within last 30 days at the time of screening.

Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.

Study & Design

• Study Type: PMS
• Study Design: Not specified