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CTRI Number  CTRI/2025/10/096505 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 26/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing vitamin B12 given by mouth versus injection in children with Infantile Tremor Syndrome. 
Scientific Title of Study   Comparison of efficacy and safety of oral versus intramuscular vitamin B12 in children with infantile tremor syndrome: a randomized-controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suraj Kumar Jha 
Designation  Post Graduate Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Paediatrics AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9229352397  
Fax    
Email  surajjha11442@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indar Kumar Sharawat 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Paediatrics Paediatric Neurology Division AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9560182301  
Fax    
Email  sherawatdrindar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Indar Kumar Sharawat 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Paediatrics Paediatric Neurology Division AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9560182301  
Fax    
Email  sherawatdrindar@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Rishikesh 
Address  All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249 203, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suraj Kumar Jha  AIIMS Rishikesh  Department of Paediatrics Paediatric Neurology Division AIIMS Rishikesh
Dehradun
UTTARANCHAL 		 9229352397

surajjha11442@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vitamin B12  Arm A: Oral vitamin B12 group Each participant will receive once daily 1000 mcg (1 mg) of oral vitamin B12 (hydroxycobalamin), liquid syrup formulation (5 ml/500 mcg) 2ml once daily for 2 weeks 
Comparator Agent  Vitamin B12  Arm B: Intramuscular vitamin B12 group Each participant will receive once daily 1000 mcg (1 mg) of intramuscular vitamin B12 (hydroxycobalamin) on anterolateral thigh for 2 weeks 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  2.00 Year(s)
Gender  Both 
Details  1. Children aged 6 months to 2 years
2. Confirmed diagnosis of ITS
 
 
ExclusionCriteria 
Details  1.Parents not consenting for participation in the trial
2. Previously documented allergy to vitamin B12
3. Severe illness requiring PICU admission/Mechanical ventilation
4. Children who have received oral or injectable vitamin B12 within 1 month prior to admission

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure will be Assessment of ITS severity score, development quotient and caregiver assessment of tremor severity by Likert scale as compared to baseline in both groups  1 weeek, 2 weeks, 8 weeks, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Motor DQ
Mental DQ
Full- scale DQ
Caregiver assessment of tremor severity by Likert scale in both groups
Serum B12 level, Hb level
MCV, TLC, total platelets count
Serum Homocysteine level
 		 2 weeks 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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)   06/11/2025 
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="2"
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [surajjha11442@gmail.com].

  6. For how long will this data be available start date provided 29-10-2025 and end date provided 29-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Infantile Tremor Syndrome is a neuroregressive disorder linked to vitamin B12 deficiency in infants and young children. Although intramuscular vitamin B12 is the current standard of care, its painful administration, poor compliance, and limited feasibility in low resource settings necessitate the evaluation of an effective and more acceptable oral alternative. This randomized controlled trial aims to compare the efficacy and safety of oral versus intramuscular vitamin B12 supplementation in the treatment of children with Infantile Tremor Syndrome. The study will include children aged six months to two years with a confirmed diagnosis of Infantile Tremor Syndrome. Participants will be randomly allocated in a one to one ratio into two groups using block randomization. Group one will receive oral vitamin B12 and group two will receive intramuscular vitamin B12. The primary outcome will be the change in tremor severity score at two weeks compared to baseline. Secondary outcomes will include changes in serum vitamin B12, homocysteine, hemoglobin, mean corpuscular volume, leukocyte and platelet counts, developmental quotient, caregiver impression of tremor severity, and frequency of treatment emergent adverse effects. The study will be conducted at the Pediatric Neurology Division, Department of Pediatrics, AIIMS Rishikesh, over a duration of twenty four months. Data will be collected using a structured proforma and analyzed using SPSS version 26.0. The results are expected to determine whether oral vitamin B12 is as effective and safe as intramuscular vitamin B12, potentially offering a simpler and patient friendly treatment option for Infantile Tremor Syndrome in resource constrained settings. 
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