Treatment of vitamin B 12 deficiency in adult subjects by using Methylcobalamin (250 �µg/Spray) nasal spray

Not Applicable

• Conditions: Health Condition 1: D519- Vitamin B12 deficiency anemia, unspecified

• Registration Number: CTRI/2022/08/044754
• Lead Sponsor: Dr Banshi Saboo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

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

2) Above the age of 18 years

3) Willing & able to comply with study requirements, e.g. usage of medicines as per

protocol, willing to adhere to study visit schedule, and willing to fill Patient Diary, as

indicated by written informed consent provided by the patient.

4) If women of childbearing potential are recruited they must be non-pregnant

(supported by a negative urine pregnancy test at screening), and be willing to maintain

reliable birth control throughout the study.

Exclusion Criteria

1) Lactating Women

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) Patient using any other nasal medication/device.

4) Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic

failure.

Patients on treatment with drugs that interfere with vitamin B12 assay.

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

6) Any disorder or condition that in the opinion of the investigator would prohibit study

participation or affect the study outcome.

Study & Design

• Study Type: Observational
• Study Design: Not specified