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

Not Applicable

Not yet recruiting

• Conditions: Deficiency of other specified B group vitamins,

• Registration Number: CTRI/2020/08/027422
• Lead Sponsor: Dr Dushyant Balat

Brief Summary

Vitamin B12, also known as cobalamin,antipernicious - anemia factor, Castle’s extrinsic factor, or animal proteinfactor is the largest and most complex of all the vitamins. It is necessary forthe formation of blood cells, nerve sheaths and various proteins. It is alsoinvolved in fat and carbohydrate metabolism. It is also essential for DNAsynthesis, for cellular energy production and growth. Vitamin B12 is alsorequired in the synthesis of folate polyglutamates (active co-enzymes requiredin the formation of nerve tissue) and in the regeneration of folic acid duringred blood cell formation. Evidenceindicates methylcobalamin is utilized more efficiently than cyanocobalamintoincrease levels of one of the coenzyme forms of vitamin B12.Experiments have shown similar absorption of methylcobalamin &cyanocobalamin following oral administration. Also, the quantity of cobalamindetected following a small oral dose of methylcobalamin is similar to theamount following administration of cyanocobalamin; but significantly morecobalamin accumulates in liver tissue following administration of methylcobalamin. Thetreatment of choice for cobalamin deficiency has been the administration ofcobalamin by intramuscular injections. In case of oral supplementation,approximately only 1% of ingested B12 is absorbed via thegastrointestinal tract requiring IF factor and other transport proteins for properabsorption. So requirement of high doses and co transporters limit the use oforal cobalamin form. NasalMethylcobalamin therapy has been recently introduced as an innovative route forthe systemic availability of B12 due to the large surface area, porousendothelial membrane, high total blood flow, the avoidance of first-passmetabolism, and ready accessibility of the route. Methylcobalamin is absorbedrapidly, safely and consistently from the nasal cavity after intranasaladministration. Further, intranasal formulation has overcome the drawbacks ofintramuscular formulation.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-08-19
• Study Start: 2020-08-27

Recruitment & Eligibility

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

Inclusion Criteria

• Patients meeting all of the following will be included in the study: Vitamin B12 level < 200 pg/mL (148 pmol/L) 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

• 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.

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 of Nasal B12(Group -A), oral B12(Group-B) and Intramuscular B12 Injection (Group-C) ]	Day 7 and day 14

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving Vitamin B12 levels ≥ 200 pg/mL and ≥ 400 pg/mL on day 7 and on day 14	Day 7 and day 14

Trial Locations

Locations (1)

Apollo Hospitals International Ltd; 🇮🇳 Gandhinagar, GUJARAT, India

Apollo Hospitals International Ltd

🇮🇳Gandhinagar, GUJARAT, India

Dr Dushyant Balat

Principal investigator

9825015055

drdushyant.balat@gmail.com