| CTRI Number |
CTRI/2024/10/075521 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of the therapeutic effects of different methods of vitamin B12 administration—through the nose, muscle injection, and intravenous injection—on blood-related health indicators in individuals with B12 deficiency anemia. |
|
Scientific Title of Study
|
comparing the therapeutic effects of intranasal, intramuscular, intravenous B12 administration on haematological parameters in B12 deficiency anaemia |
| Trial Acronym |
CHAMPION B12 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahil Arora |
| Designation |
Clinical Tutor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Internal Medicine, AFMC, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7986067569 |
| Fax |
|
| Email |
rahilarora1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahil Arora |
| Designation |
Clinical Tutor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Internal Medicine, AFMC, Pune
MAHARASHTRA
411040
India |
| Phone |
7986067569 |
| Fax |
|
| Email |
rahilarora1992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahil Arora |
| Designation |
Clinical Tutor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Internal Medicine, AFMC, Pune
MAHARASHTRA
411040
India |
| Phone |
7986067569 |
| Fax |
|
| Email |
rahilarora1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Internal Medicine, Armed Forces Medical College, Pune |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Armed Forces Medical College, Pune-411040 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rahil Arora |
Armed Forces Medical College |
Room 1, Department of Internal Medicine, Armed Forces Medical College, Pune-411040
Pune
MAHARASHTRA |
7986067569
rahilarora1992@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D510||Vitamin B12 deficiency anemia dueto intrinsic factor deficiency, (2) ICD-10 Condition: D511||Vitamin B12 deficiency anemia dueto selective vitamin B12 malabsorption with proteinuria, (3) ICD-10 Condition: D512||Transcobalamin II deficiency, (4) ICD-10 Condition: D518||Other vitamin B12 deficiency anemias, (5) ICD-10 Condition: D519||Vitamin B12 deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intramuscular B12 |
Patients diagnosed with B12 deficiency anaemia (based on WHO criteria) will be administered IM B12 once a day for 07 days followed by weekly dose for 04 weeks |
| Comparator Agent |
Intravenous B12 |
Patients diagnosed with B12 deficiency anaemia (based on WHO criteria) will be administered IV B12 once a day for 07 days followed by once a week for 04 weeks |
| Intervention |
Nasal B12 |
Patients diagnosed with B12 deficiency anaemia (based on WHO criteria) will be administered nasal B12 250 micrgrams alternate day for 07 doses followed by weekly dose for 04 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with B12 deficiency anaemia. Willingness to give consent |
|
| ExclusionCriteria |
| Details |
1. Pregnant females
2. All other causes of anaemia
3. Requiring blood transfusion at initiation of therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COMPARE THE CHANGE IN HEMATOLOGICAL PARAMETERS (HAEMOGLOBIN, MEAN CORPUSCULAR VOLUME) |
COMPARE THE CHANGE IN HEMATOLOGICAL PARAMETERS (HAEMOGLOBIN, MEAN CORPUSCULAR VOLUME) ON DAY 14 AND DAY 28 IN EACH GROUP (INTRAVENOUS, INTRAMSCULAR AND NASAL B12 TREATMENT AS PER ESTABLISHED GUIDELINES) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "167"
Final Enrollment numbers achieved (India)="167" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
28/10/2025 |
| 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 - NO
|
Brief Summary
Modification(s)
|
A total of 100 patients will be enrolled in the study. These 100 patients will be randomised by computer generated random number sequence into three groups. All patients who are diagnosed as B12 deficiency will be administered intravenous, intramuscular and nasal B12 based on treatment protocol. The response in hematological parameters will be assessed on 07th, 14th and 28th day of treatment. |