A clinical study to evaluate the effect of Methylcobalamine nasal spray in patients with subclinical cobalamin deficiency.

Phase 4

Completed

• Conditions: Health Condition 1: D618- Other specified aplastic anemias and other bone marrow failure syndromes

• Registration Number: CTRI/2020/10/028370
• Lead Sponsor: Dr Sudhir Kumar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Vitamin B12 level [200 pg/mL ââ?¬â?? 399pg/mL ( 148pmol/L ââ?¬â?? 295pmol/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 with study visit schedule and willing to fill Patient Diary, as indicated by written informed consent provided by the patient.

4) Study population will be EITHER any of the following in either gender:

a) General Population

b) Patients who are on Metformin (�1000mg/day) therapy for � 4 months

c) Anaemic patients having hemoglobin level of < 9g/dL

d) Chronic Alcoholic Patients as per DSM V criteria

e) Patients on PPI therapy for � 6 months

f) 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:

g) Women on Oral Contraceptive Pills

h) Women with Poly Cystic Ovarian Disease(PCOD) on Metformin

5) 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

1) 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.

4) Patient using any other nasal medication/device.

5) Patients having a known diagnosis of severe renal impairment or renal failure. Patients on treatment with drugs which interfere with vitamin B12 assay.

6) Participated in any clinical trial within last 30 days at the time of screening.

7) Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and efficacy of Vitamin B12 in comparison of changes in Vitamin B12 levels post 30 days(i.e, 08 doses for Group-A and 30 doses for Group-B)Timepoint: To evaluate the safety and efficacy of Vitamin B12 in comparison of changes in Vitamin B12 levels post 30 days(i.e, 08 doses for Group-A and 30 doses for Group-B)

Secondary Outcome Measures

Name	Time	Method
1) Proportion of subjects achieving Vitamin B12 levels (300 pg/ml) on day 31 (Group-B) and (Group-A) <br/ ><br> <br/ ><br>2) Proportion of subjects achieving Vitamin B12 levels (200-399 pg/ml) on day 31 (Group-B) and (Group-A)Timepoint: end of the study