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

Not yet recruiting

• Conditions: Vitamin B12 deficiency anemia, unspecified,

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

Brief Summary

Vitamin B12, also known as cobalamin, anti-pernicious anaemia factor, Castle’s extrinsicfactor, or animal protein factor is the largest and most complex of all the vitamins. It isnecessary for the formation of blood cells, nerve sheaths, and various proteins. It is alsoinvolved in fat and carbohydrate metabolism. It is also essential for DNA synthesis, cellularenergy production, and growth. Vitamin B12 is also required in the synthesis of folatepolyglutamates (active coenzymes required in the formation of nerve tissue) and in theregeneration of folic acid during red blood cell formation. Cobalamin Deficiency is definedas B12 levels <200pg/mL and SCCD or Subclinical Cobalamin Deficiency refers to B12 levels<400pg/mL.Nasal Methylcobalamin therapy has been recently introduced as an innovative route for thesystemic availability of B12 due to the large surface area, porous endothelial membrane, hightotal blood flow, the avoidance of first-pass metabolism, and ready accessibility of the route.Methylcobalamin is absorbed rapidly, safely, and consistently from the nasal cavity afterintranasal administration. Further, the intranasal formulation has overcome the drawbacks ofthe intramuscular formulation. It is convenient and painless. Nasal Methylcobalamin Spraycan eliminate the need for the assistance of Nursing staff or Paramedics for injection andreduce the overall cost of therapy. It would also facilitate ease of administration and improvecompliance.The aim of study is to evaluate the safety and effectiveness of novel methylcobalamin nasalspray in the treatment of subjects with vitamin B12 deficiency. the primary end points are to Change in Vitamin B12 levels on day 8 from Baseline [i.e. after 07 doses of NasalB12] and Change in Vitamin B12 levels on day 14 from Baseline [i.e. after 14 doses of NasalB12].

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-24
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

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

Primary Outcome Measures

Name	Time	Method
2. Change in Vitamin B 12 levels on day 14 from Baseline [i.e. after 14 doses of Nasal	15 Days
1. Change in Vitamin B 12 levels on day 8 from Baseline [i.e. after 07 doses of Nasal	15 Days
B 12 ]	15 Days

Secondary Outcome Measures

Name	Time	Method
1. The proportion of subjects achieving Vitamin B12 levels ≥ 200 pg/mL on day 8.	2. The proportion of subjects achieving Vitamin B12 levels ≥ 400 pg/mL on day 8

Trial Locations

Locations (1)

Dia Care Research; 🇮🇳 Ahmadabad, GUJARAT, India

Dia Care Research

🇮🇳Ahmadabad, GUJARAT, India

Dr Banshi Saboo

Principal investigator

9824047676

banshisaboo@hotmail.com