| CTRI Number |
CTRI/2026/01/100461 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Compare the efficacy of Intramuscular Vs Intravenous Injection of Vitamin B12 in SAM Children |
|
Scientific Title of Study
|
Comparison of Intramuscular versus Intravenous Vitamin B12 Supplementation in Children with Severe Acute Malnutrition and Vitamin B12 Deficiency |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha Patil R |
| Designation |
Post graduate |
| Affiliation |
KMCRI , HUBBALLI |
| Address |
Department of Pediatrics, room no 104 Karnataka medical college and reasearch institute , Vidyanagar Hubballi
Dharwad
KARNATAKA
580021
India |
| Phone |
7349510698 |
| Fax |
|
| Email |
varsha.rp08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod H Ratageri |
| Designation |
Professor and Head of the department , Pediatrics |
| Affiliation |
KMCRI , HUBBALLI |
| Address |
Department of Pediatrics, room no 104 Karnataka medical college and reasearch institute , Vidyanagar Hubballi
Dharwad
KARNATAKA
580021
India |
| Phone |
9448278480 |
| Fax |
|
| Email |
vhratageri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Patil R |
| Designation |
Post graduate |
| Affiliation |
KMCRI , HUBBALLI |
| Address |
Department of Pediatrics, room no 104 Karnataka medical college and reasearch institute , Vidyanagar Hubballi
Dharwad
KARNATAKA
580021
India |
| Phone |
7349510698 |
| Fax |
|
| Email |
varsha.rp08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics ,104Karnataka medical College and Research Institute Hubballi,Vidhyanagar,Hubballi_580021 |
|
|
Primary Sponsor
|
| Name |
Dr Varsha Patil R |
| Address |
Karnatak Medical college and research institute, hubballi 580021, karnataka , india |
| Type of Sponsor |
Other [Dr Varsha Patil R] |
|
|
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 Varsha Patil R |
NRC Department of P eadiatrics KMCRI Hubballi |
Department of Peadiatrics ,Room NO -104 ,Karnataka Medical College and Research Institute Vidyanagar, Hubballi - 580021
Dharwad
KARNATAKA |
7349510698
varsha.rp08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCRI HUBBALLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Infants and children aged 6 months to 5 years who are admitted to the NRC with severe acute malnutrition
with vitamin B12 deficiency |
|
| ExclusionCriteria |
| Details |
(1)Hemoglobin lessthan 5 gper dL requiring urgent transfusion
(2)Children with SAM who have acute life threatening complications requiring ICU care,
(3)Those with known disorders of B12 absorption or metabolism (e.g. short gut, congenital B12
malabsorption),
(4)Those who received vitamin B12 injection per oral in the past 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Biochemical vitamin B12 correction at8 days, defined as serum vitamin B 12 morethan 200 pg per mL |
Biochemical vitamin B12 correction at8 days, defined as serum vitamin B 12 morethan 200 pg per mL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemoglobin improvement
ii)
MUAC gain: Continuous outcome – change in mid-upper arm circumference (in cm) from
baseline to week 2. We will also assess the average weekly MUAC increment and the proportion
of children who achieve MUAC more than 11.5 cm (threshold for exiting SAM) by 4 weeks.
iii)
Neurological recovery: This is a composite, qualitative outcome. We will use clinical criteria
such as improvement in muscle tone (e.g. from hypotonia to normal tone), alertness and activity,
and developmental progress.
Adverse events: All adverse events will be documented and classified by severity and relation
to intervention. Key outcomes will be the occurrence of any injection site complications (like
swelling, abscess, nerve injury symptoms) in the IM group versus any IV infusion complications
(phlebitis, extravasation) in the IV group |
Hemoglobin improvement
ii)
MUAC gain: Continuous outcome – change in mid-upper arm circumference (in cm) from
baseline to week 2. We will also assess the average weekly MUAC increment and the proportion
of children who achieve MUAC more than11.5 cm (threshold for exiting SAM) by 4 weeks.
iii)
Neurological recovery: This is a composite, qualitative outcome. We will use clinical criteria
such as improvement in muscle tone (e.g. from hypotonia to normal tone), alertness and activity,
and developmental progress.
Adverse events: All adverse events will be documented and classified by severity and relation
to intervention. Key outcomes will be the occurrence of any injection site complications (like
swelling, abscess, nerve injury symptoms) in the IM group versus any IV infusion complications
(phlebitis, extravasation) in the IV group |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
SAM is strongly associated with micronutrient deficiencies ,Particularly vitamin B12.Current WHO and Indian guidelines recommend broad spectrum micronutrients including B12 but lack clarity on optimal administration routes.IM injections are standard but Painful ,risky in Children with low muscle mass.Hence IV Vitamin B12 may be viable alternative,Offering faster bioavailability and fewer Complications,especially in hospitalized SAM Children who already have IV access.However Comparative data on IM Vs IV routes in this population are lacking.Hence,this Study aims to evaluate whether IV B 12 is safer and equally or more effective option in managing SAM with B 12 deficiency. |