| CTRI Number |
CTRI/2024/10/074903 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of vitamin B12 deficiency in children |
|
Scientific Title of Study
|
Low versus high oral dose of vitamin B12 for treatment of macrocytic anemia: a randomised controlled trial in a District hospital |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin Kumar Singhal |
| Designation |
DNB resident pediatrics |
| Affiliation |
Government Multi Speciality hospital -16 Chandigarh |
| Address |
Department of pediatrics, Govt multispeciality hospital, sector 16 Chandigarh , Chandigarh, India
Chandigarh
CHANDIGARH
160015
India |
| Phone |
07976701029 |
| Fax |
7976701029 |
| Email |
sachin27081999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Kiran Singh |
| Designation |
Medical officer,Pediatrics |
| Affiliation |
Government Multi Speciality hospital-16 Chandigarh |
| Address |
Department of pediatrics,Government Multi Speciality hospital sector 16, Chandigarh, Chandigarh, India
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9814735929 |
| Fax |
9814735929 |
| Email |
singhshashikiran72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashi Kiran Singh |
| Designation |
Medical officer,Pediatrics |
| Affiliation |
Government Multi Speciality hospital-16 Chandigarh |
| Address |
Department of pediatrics,Government Multi Speciality hospital sector 16, Chandigarh, Chandigarh,India
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9814735929 |
| Fax |
9814735929 |
| Email |
singhshashikiran72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Multi-speciality hospital sector 16 Chandigarh 160016, India |
|
|
Primary Sponsor
|
| Name |
Govt Multi speciality hospital sector Chandigarh |
| Address |
Department of pediatrics,Govt. Multi speciality hospital sector 16 Chandigarh, 160016 |
| 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 Sachin Kumar Singhal |
Govt. Multi speciality hospital sector 16 Chandigarh |
Department of pediatrics, Government Multi Speciality hospital sector 16, Chandigarh, Chandigarh,India
Chandigarh
CHANDIGARH |
07976701029
sachin27081999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee gmsh Chandigarh sector 16, Chandigarh 160015 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D519||Vitamin B12 deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Higher dose of vit. B12 |
Less than 2yr. - 1000μg
More than 2yr. - 1500μg
For 1 month |
| Intervention |
Vitamin B12 lower dose |
Less than 2yr. - 750μg
More than 2yr. - 1000μg
For 1 month |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All children between 2month to 12 years age with vit. B12 deficiency & symptoms will be included. |
|
| ExclusionCriteria |
| Details |
1. Neurological symptoms other than infantile tremor syndrome.
2. Those who have received blood transfusion or vit. B12 therapy upto one month prior to admission |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of change in serum vitamin B12 level after treatment between 2 groups. |
At 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of changes in level of hematological parameters between 2 groups. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
15/10/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 study will include children from 2 month to 12 years age with vitamin B12 deficiency symptoms or macrocytic picture in peripheral blood film. After confirming vitamin B12 level below threshold the children will be given vit. B12 suppliment for 1 month in 2 groups. 1st group will get low doses of vitamin B12 for 1 month while 2nd group will be supplimented by higher dose of vitamin B12. After 1 month of treatment duration comparison between vitamin B12 level & other hematological parameters will be done, which will help us finding the correct dose for treatment of vitamin B12 deficiency. |