| CTRI Number |
CTRI/2024/10/075367 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
comparing the efficacy and safety of a new Vitamin B 12 Nasal Spray vs Oral Supplement in treating Vitamin B 12 Deficiency |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sabah Siddiqui |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE (AIIMS) |
| Address |
Room No 1111 Medical College Complex First Floor Gate No 05 All India Institute of Medical Science (AIIMS) G E Road Tatibandh Raipur 492099 Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881911 |
| Fax |
8518881911 |
| Email |
dr.sabahsiddiqui@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabah Siddiqui |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE (AIIMS) |
| Address |
Room No 1111 Medical College Complex First Floor Gate No 05 All India Institute of Medical Science (AIIMS) G E Road Tatibandh Raipur 492099 Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881911 |
| Fax |
8518881911 |
| Email |
dr.sabahsiddiqui@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabah Siddiqui |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE (AIIMS) |
| Address |
Room No 1111 Medical College Complex First Floor Gate No 05 All India Institute of Medical Science (AIIMS) G E Road Tatibandh Raipur 492099 Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881911 |
| Fax |
8518881911 |
| Email |
dr.sabahsiddiqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| all India Institute of Medical Science (AIIMS) G.E Road Tatibandh Raipur-492099 Chhattisgarh
|
|
|
Primary Sponsor
|
| Name |
Dr Sabah Siddiqui |
| Address |
Room No 1111 Medical College Complex First Floor Gate No. 05 All India Institute of Medical Science (AIIMS) G E Road Tatibandh Raipur 492099 Chhattisgarh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Sabah Siddiqui |
All India Institute of Medical Science (AIIMS) |
Room No. 1111 General Medicine First Floor Medical College Complex Gate No. 05 All India Institute of Medical Science (AIIMS) G.E Road Tatibandh Raipur-492099
Raipur
CHHATTISGARH |
8518881911
8518881911
dr.sabahsiddiqui@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Science Raipur-492099 Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G09||Sequelae of inflammatory diseasesof central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Methylcobalamin Nasal spray and methyl cobalamin tablet |
Test Group Methylcobalamin nasal spray 250 µg per spray
Dose and Administration Total 11 doses (500 mcg per day through two sprays: one spray in each nostril) will be administered on alternate-day as follows: Day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21
Reference Group: Oral B12 tablets (500 mcg/day, as metylcobalamine).
Dose and Administration: Oral B12 tablets 500 mcg per day) on day 1 ,3, 5, 7, 9, 11, 13, 15, 17, 19 and 21.
Total 11 doses of 500 µg of methylcobalamin over the period of 3 weeks will be administered in both the treatment groups. After the completion of study treatment, each patient will visit the study site weekly for 2 weeks and at every 2 weeks thereafter till 15 weeks (12 weeks after maintenance phase) or till the Vitamin B12 level reach 200 pg/mL, whichever earlier. Any patient not maintain Vitamin B12level 200 pg per mL, will be withdrawn from the study during follow up and their end study visit procedures will be completed
|
| Comparator Agent |
Methylcobalamine Tablet 500 mg |
Reference Group: Oral B12 tablets (500 mcg/day, as metylcobalamine).
Dose and Administration: Oral B12 tablets 500 mcg per day) on day 1 ,3, 5, 7, 9, 11, 13, 15, 17, 19 and 21.
Total 11 doses of 500 µg of methylcobalamin over the period of 3 weeks will be administered in both the treatment groups. After the completion of study treatment, each patient will visit the study site weekly for 2 weeks and at every 2 weeks thereafter till 15 weeks (12 weeks after maintenance phase) or till the Vitamin B12 level reach 200 pg/mL, whichever earlier. Any patient not maintain Vitamin B12level 200 pg per mL, will be withdrawn from the study during follow up and their end study visit procedures will be completed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
• Patient using any other nasal medication/device.
• 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.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference in Vitamin B12 level level between the treatment arms at various time-points |
105 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2024 |
| Date of Study Completion (India) |
05/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sabahsiddiqui@gmail.com].
- For how long will this data be available start date provided 10-10-2024 and end date provided 31-12-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
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’. |