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comparing the efficacy and safety of a new Vitamin B 12 Nasal Spray vs Oral Supplement in treating Vitamin B 12 Deficiency

A prospective, open-label, randomized, comparative clinical trial to assess theefficacy and safety of a novel Methylcobalamin Nasal Spray (NASO B12) or oral B12 supplementation in the treatment of subjects with vitamin B12 deficiencyas well as to evaluate the duration of efficacy - Nill

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075367
Enrollment
50
Registered
2024-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: G09- Sequelae of inflammatory diseasesof central nervous system

Interventions

Intervention1: Methylcobalamin Nasal spray and methyl cobalamin tablet: Test Group Methylcobalamin nasal spray 250 µg per spray Dose and Administration Total 11 doses (500 mcg per day through two spr

Sponsors

Dr Sabah Siddiqui
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female adult patients of age 18 years or more Vitamin B12 level 200 pg/mL 148 pmolL 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 • 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 Pregnanat or Lactating Women 2 Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication. 3 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/hepatic impairment or renal/hepatic failure. • Patients on treatment with drugs that interfere with vitamin B12 assay.

Design outcomes

Primary

MeasureTime frame
To compare the difference in Vitamin B12 level level between the treatment arms at various time-pointsTimepoint: 105 days—

Secondary

MeasureTime frame
The secondary objective of the proposed study is to evaluate the effect of novel methylcobalamin nasal spray supplementation on Hemoglobin and Reticulocyte count and duration of efficacy for Vitamin B12status as well as to evaluate safety of novel methylcobalamin nasal spray in comparision to Oral Vitamin B12 supplementationTimepoint: 105 DAYS—

Countries

India

Contacts

Public ContactDr Sabah Siddiqui

ALL INDIA INSTITUTE OF MEDICAL SCIENCE (AIIMS)

dr.sabahsiddiqui@gmail.com8518881911

Outcome results

None listed

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