To check the effectiveness and safety of Methylcobalamin nasal spray in comparison with oral methylcobalamin tablet and methylcobalamin injection.

A prospective, randomized, open label, clinical study to evaluate safety and effectiveness of novel methylcobalamin nasal spray compared to oral methylcobalamin in the treatment of vitamin B12 deficiency.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027422

Enrollment

100

Registered

2020-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E538- Deficiency of other specified B group vitamins

Interventions

Intervention1: Methylcobalamin Nasal Spray: Total dose of 500 mcg of Methylcobalamin Nasal Spray, 250 mcg in each dose/spray on every alternate day for 15 days Control Intervention1: Methylcobalamin O

Eligibility

Inclusion criteria

Inclusion criteria: Patients meeting all of the following will be included in the study: Vitamin B12 level 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. 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

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.

Design outcomes

Primary

Measure	Time frame
Comparison of change in Vitamin B12 levels on day 7 of Nasal B12(Group -A), oral B12(Group-B) and Intramuscular B12 Injection (Group-C) ]Timepoint: Day 7 and day 14	—

Secondary

Measure	Time frame
Proportion of subjects achieving Vitamin B12 levels â?¥ 200 pg/mL and â?¥ 400 pg/mL on day 7 and on day 14Timepoint: Day 7 and day 14	—

Countries

India

Contacts

Public ContactDr Dushyant Balat

Apollo Hospitals International Ltd Gandhinagar

drdushyant.balat@gmail.com9825015055

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026