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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dr Sabah Siddiqui
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To compare the difference in Vitamin B12 level level between the treatment arms at various time-points
Overview
Brief Summary
This will be a prospective, randomized, open-label, comparative clinical study. 50 patients having vitamin B12 deficiency will be enrolled in this study. Enrolled patients will be randomized in 2 groups in 1:1 ratio as per reandomizationto receive either the novel methylcobalamin nasal spray (test group) or oral supplement (reference group). According to randomization, patients of test group will receive a novel Methylcobalamin nasal spray 250 µg/spray “NASO B12†and reference group II patient will receive Oral B12 tablets. Patients of both the groups will receive either novel Methylcobalamine nasal spray or oral B12on day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21 (on alternate days for total 11 days). After treatment, each patient will be followed up till week 15(12 weeks after treatment period) or Vitamin B12 level reach < 200 pg/mL; whichever earlier.
As this study is IIS (Investigator Inititated Study), no regulatory approval is required to initiate the study. The study will be initiated only after getting approval from Independent/Institutional ethics committee. The study will be carried out according to the protocol approved by the IEC/IRB of the participating institution in accordance with Declaration of Helsinki (Brazil, October 2013) and as per the New Drugs and Clinical Trial Rules, 2019, Ethical guidelines for biomedical research on human participants, ICMR (Indian Council of Medical Research (2006)] and ICH (International Conference on Harmonization) E6 ‘Guideline for Good Clinical Practice- Consolidated Guidance for Industry’.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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
- •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.
- •â€¢ Patient using any other nasal medication/device.
- •â€¢ Patients having a known diagnosis of severe renal/hepatic impairment or renal/hepatic failure.
- •â€¢ Patients on treatment with drugs that interfere with vitamin B12 assay.
Outcomes
Primary Outcomes
To compare the difference in Vitamin B12 level level between the treatment arms at various time-points
Time Frame: 105 days
Secondary Outcomes
- 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 supplementation(105 DAYS)
Investigators
Dr Sabah Siddiqui
ALL INDIA INSTITUTE OF MEDICAL SCIENCE (AIIMS)