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CTRI Number  CTRI/2025/10/096291 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Providing Vitamin D in children taking antiseizure medicines and children not on medication to find appropriate dose of Vitamin D to prevent deficiency 
Scientific Title of Study   High dose vs low dose Vitamin D Supplementation in epileptic children taking anti-seizure medication: A Randomised Control 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  Dr Nishank Cariappa K P 
Designation  Post Graduate 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION 
Address  JSS Department of Paediatrics, JSS Hospital, JSS Academy of Higher Education, Mysore-570004

Mysore
KARNATAKA
570004
India 
Phone  9845032887  
Fax    
Email  nishankcariappa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chetak K B 
Designation  Professor 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION 
Address  Department of Paediatrics, JSS Hospital, JSS Academy of higher Education, Mysore Karnataka India

Mysore
KARNATAKA
570004
India 
Phone  9844778712  
Fax    
Email  drchetak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chetak K B 
Designation  Professor 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION 
Address  Department of Paediatrics, JSS Hospital, JSS Academy of higher Education, Mysore Karnataka, India

Mysore
KARNATAKA
570004
India 
Phone  9844778712  
Fax    
Email  drchetak@gmail.com  
 
Source of Monetary or Material Support  
JSS Hospital, JSS Academy of Higher Research and Education Mysore India- 560004  
 
Primary Sponsor  
Name  JSS Hospital  
Address  Dept of Pediatrics, JSS Hosptial, JSS Academy of Higher Education Mysuru-570004 
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 Nishank Cariappa  JSS Hospital, Mysuru  JSS Hosptial, Department of Paediatrics, Paediatric OPD Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004
Mysore
KARNATAKA 		 9845032887

nishankcariappa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSSAHER Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vitamin D prophylaxis  High Dose Group: Supplemented with 2000 IU/day of Vitamin D to be given for 6 months  
Comparator Agent  Vitamin D prophylaxis  Low Dose Group: Supplemented with 600IU/day of Vitamin D to be given for 6 months  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All children between 1-18 years of age who are known cases of seizure disorder or newly diagnosed cases of epilepsy and taking any monotherapy antiseizure medication.  
 
ExclusionCriteria 
Details  1. Child is on polytherapy
2. Children suffering from inborn errors of metabolism
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Vitamin D in both groups after 6 months of vitamin D supplementation  Prevalence of Vitamin D in both groups after 6 months of vitamin D supplementation 
 
Secondary Outcome  
Outcome  TimePoints 
1. To analyse occurrence of breakthrough seizures in both groups and role of Vitamin D in prevention of recurrence of seizures.
2. To analyse Ca, ionised Calcium, serum phosphate and alkaline phosphatase in both groups
 		 6 months following start of Vitamin D, the patients are assessed for bone health and breakthrough seizures.  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/11/2025 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 27-12-2027 and end date provided 25-12-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a randomised control trial which will be conducted in the Department of Paediatrics at JSS Medical College and Hospital, Mysuru, a tertiary care teaching hospital. The study will be conducted over a period of 12 months after obtaining approval from the institutional ethics committee. The study aims to supplement High dose vs low doses of Vitamin D to children between 1 year to 18 years of age diagnosed with Epilepsy and taking Monotherapy anti-seizure medication and to establish the better dose of Vitamin D to combat the Vitamin D deficiency in epileptic children taking anti-seizure medication. This is a single-centre study with simple random sampling of eligible children presenting to the OPD and in-patient services.

All children fulfilling the inclusion criteria will be enrolled after obtaining written informed consent from parents or guardian. Vitamin D levels, Calcium, Ionised Calcium, Serum Phosphate and Alkaline Phosphatase will be taken during the first visit. If baseline Vitamin D levels are low, they will be treated with Vitamin D sachets according to Stoss Therapy, 60,000 IU/week for 6 weeks. Repeat Vitamin D testing will be done at the end of 6 weeks. If the Vitamin D levels are normal they will be included in the study. The children will be randomised into high-dose (2000IU/day) and low-dose groups(600IU/day) for a period of six months. They will then be supplemented with oral Vitamin D according to their group. If baseline Vitamin D levels are low, they will be treated with Vitamin D sachets according to Stoss Therapy, 60,000 IU/week for 6 weeks. Repeat Vitamin D testing will be done at the end of 6 weeks. If the Vitamin D levels are normal they will be included in the study.  Repeat tests for Vitamin D, Calcium, Ionised Calcium, Serum Phosphate and Alkaline Phosphatase will be taken after 6 months. The values will be recorded, compared after six months and analysed to find the prevalence of Vitamin D deficiency, bone health and breakthrough seizures in both groups.  


 
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