| CTRI Number |
CTRI/2024/05/067371 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [VITAMIN B12 SUPPLEMENTATION IN VITAMIN B12 DEFICIENT ANEMIA] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see change in serum b12 level by parenteral and oral vitamin b12 supplemention |
|
Scientific Title of Study
|
A study to compare changes in serum vitamin b12 levels by oral and parenteral regimens in children with vitamin b12 deficient children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ARVIND BISHNOI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR SAMPURNANAND MEDICAL COLLEGE ,JODHPUR |
| Address |
Devision of hematology,room no 3 janana wing,department of pediatrics ,Dr Sampurnanand medical college,jodhpur
Devision of hematology,room no 3 janana wing,department of pediatrics ,Dr Sampurnanand medical college,jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9116867362 |
| Fax |
|
| Email |
vishnoi656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAMOD SHARMA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
DR SAMPURNANAND MEDICAL COLLEGE ,JODHPUR |
| Address |
Devision of pediatric hematology ,room no 4 janana wing department of pediatrics,Dr Sampurnanand medical college,jodhpur
Devision of pediatric hematology ,room no 4 janana wing department of pediatrics,Dr Sampurnanand medical college,jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9929744666 |
| Fax |
|
| Email |
drpramodsha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAMOD SHARMA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
DR SAMPURNANAND MEDICAL COLLEGE ,JODHPUR |
| Address |
Devision of pediatric hematology ,room no 4 janana wing department of pediatrics,Dr Sampurnanand medical college,jodhpur
Devision of pediatric hematology ,room no 4 janana wing department of pediatrics,Dr Sampurnanand medical college,jodhpur
Jodhpur
RAJASTHAN
307030
India |
| Phone |
9929744666 |
| Fax |
|
| Email |
drpramodsha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Samprnanand Medical college Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sampurnanand Medical College |
| Address |
Dr Sampurnanand Medical College,Jodhpur |
| Type of Sponsor |
Government medical college |
|
|
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 ARVIND BISHNOI |
Mathuradas mathur hospital,Umaid Hospital |
Department of pediatrics, Dr Sampurnanand medical college ,Jodhpur
Jodhpur
RAJASTHAN |
9116867362
vishnoi656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR S N MEDICAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: D513||Other dietary vitamin B12 deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMPARISION WILL BE DONE BETWEEN SERUM VITAMIN B12 LEVELS OF PATIENTS WHO HAVE RECEIVED ORAL AND THOSE WHO HAVE RECEIVED PARENTERAL B 12 SUPPLEMENTATION |
Doses of vitamin B12
ORAL(Tablet Methycobalamin)
6months to 5years old 250microgramsone tablet once a day for 6 weeks then once a week
6 years to 10 years 500microgramsone tablet once a day for 6 weeks then once a week
12 years to 18 years 1000microgramsone tablet once aday for 6 weeks then once a week
PARENTERAL
Below 10 year 500µgper dayofvitaminB12(Inj.Methylcobalamin)willbegivenIM(orintravenousifplateletcount less tha 50×109 per L)once everydayforone week thenonce a week for 7 weeks and then once every fortnight
Above 10 years 1000µg/dayofvitaminB12(Inj.Methylcobalamin)willbegivenIM(orintravenousifplateletcount less than 50×109/L)once everydayforone week thenonce a week for 7 weeks and then once every fortnight
|
| Intervention |
Vitamin b12 supplementation |
Supplementing vitamin B12 by oral and parenteral route and comparing change in serum vitamin b12 levels |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children aged 6 months to 18 year, attending OPD or admitted in the indoor wards of the Department of Pediatrics at UMAID or MDM hospital, Jodhpur with the diagnosis of nutritional anemia shall be recruited for study. |
|
| ExclusionCriteria |
| Details |
Patient with history of vitamin B12 intake in last 3 months and those who had blood tranfusions in last 1 month
Proven coeliac disease
Proven malabsorption disease
Patients not meeting hematological parameters |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in serum vitamin B12 levels after parenteral and oral vitamin B12 supplementation in vitamin B12 deficiency |
To compare the change in serum vitamin B12 levels after parenteral and oral vitamin B12 supplementation in vitamin B12 deficienc at 4 weeks,8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in hemoglobin level and normalisation of hematological indices,after supplentation with each of the regime |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a prospective randomised study to compare change in serum vitamin b12 levels by oral and parenteral regimen in children with vitamin b12 deficient anemia |