clinical study to check safety and effectiveness of novel methylcobalamin nasal spray versus oral methylcobalamin in the treatment of subjects with vitamin B12 deficiency

Not yet recruiting

• Conditions: Vitamin B deficiency, unspecified,

• Registration Number: CTRI/2020/09/028143
• Lead Sponsor: Asian Institute of Gatroentrology

Brief Summary

Vitamin B12, also known as cobalamin, antipernicious-anaemiafactor, Castle’s extrinsic factor, or animal protein factor is the largest andmost complex of all the vitamins. It is necessary for the formation of bloodcells, nerve sheaths and various proteins. It is also involved in fat andcarbohydrate metabolism. It is also essential for DNA synthesis, for cellularenergy production and growth. Vitamin B12 is also required in the synthesis offolate polyglutamates (active coenzymes required in the formation of nervetissue) and in the regeneration of folic acid during red blood cell formation. Cobalamin Deficiency is defined asB12 levels <200pg/mL and SCCD of Subclinical Cobalamin Deficiency refers toB12 levels <400pg/mL.

Nasal Methylcobalamin therapy has been recently introducedas an innovative route for the systemic availability of B12 due to the largesurface area, porous endothelial membrane, high total blood flow, the avoidanceof first-pass metabolism, and ready accessibility of the route. Methylcobalaminis absorbed rapidly, safely and consistently from the nasal cavity afterintranasal administration. Further, intranasal formulation has overcome thedrawbacks of intramuscular formulation. It is convenient and painless. NasalMethylcobalamin Spray can eliminate the need for assistance of Nursing staff orParamedics for injection and reduce the overall cost of therapy. It would alsofacilitate ease of administration and improve compliance.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-25
• Study Start: 2020-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Vitamin B12 level < 200 pg/mL (148 pmol/L) General Population Patients who are on Metformin (≥1000mg/day) therapy for ≥ 4 months Anaemic patients having hemoglobin level of < 9 g/dL Chronic Alcoholic Patients as per DSM V criteria Patients on PPI therapy for ≥ 6 months Patients who have undergone Bariatric Surgery (e.g. RYGB surgery/ Mini gastric bypass surgery/ Sleeve Gastrectomy/ Sleeve Gastroplasty etc) OR Gastric Surgery for any indication.
• OR Study population will be any of the following in female population: Women on Oral Contraceptive Pills Women with Poly Cystic Ovarian Disease(PCOD) on Metformin.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of change in Vitamin B12 levels on day 7 [i.e. after 03 doses of Nasal B12(Group -A) or 06 doses of oral B12(Group-B) ]	Day 7

Secondary Outcome Measures

Name	Time	Method
Comparison in change in Vitamin B12 levels on day 7 for Group-B and day 14 for Group-A	Comparison in change in Vitamin B12 levels on day 14 for Group-A and Group-B

Trial Locations

Locations (1)

Asian Institute of Gastroentrology; 🇮🇳 Hyderabad, TELANGANA, India

Asian Institute of Gastroentrology

🇮🇳Hyderabad, TELANGANA, India

Dr Manu Tandon

Principal investigator

04023378888

mantan_05@rediffmail.com