FindTrial
Sign In

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

A prospective, open-label, single-arm clinical study to evaluate the safety and effectiveness of novel Methylcobalamin nasal spray in the treatment of subjects with vitamin B 12 deficiency.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/08/044754
Enrollment
20
Registered
2022-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

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

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Banshi Saboo
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Vitamin B12 level 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

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.

Design outcomes

Primary

MeasureTime frame
1. Change in Vitamin B 12 levels on day 8 from Baseline [i.e. after 07 doses of Nasal B 12 ] 2. Change in Vitamin B 12 levels on day 14 from Baseline [i.e. after 14 doses of Nasal B 12 ]Timepoint: 15 Days—

Secondary

MeasureTime frame
1. The proportion of subjects achieving Vitamin B12 levels ââ?°Â¥ 200 pg/mL on day 8. 2. The proportion of subjects achieving Vitamin B12 levels ââ?°Â¥ 400 pg/mL on day 8 3. The proportion of subjects achieving Vitamin B12 levels ââ?°Â¥ 200pg/mL on day 14 4. The proportion of subjects achieving Vitamin B12 levels ââ?°Â¥ 400pg/mL on day 14Timepoint: 15 days—

Countries

India

Contacts

Public ContactDr Banshi Saboo

Dia Care Research,

banshisaboo@hotmail.com9824047676

Outcome results

None listed

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