| CTRI Number |
CTRI/2018/08/015275 [Registered on: 10/08/2018] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Supplementation] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Vitamin E in treatment resistant Epilepsy |
|
Scientific Title of Study
|
Role of vitamin E supplementation in treatment resistant epilepsy in children in the age group 1-12 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhammed Shabeer P |
| Designation |
Junior resident |
| Affiliation |
GMCH Aurangabad |
| Address |
Department of paediatrics
GMCH Aurangabad
GMCH Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9562028461 |
| Fax |
|
| Email |
mohdshabeerp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PS Patil |
| Designation |
Head and professor, department of paediatrics |
| Affiliation |
GMCH Aurangabad |
| Address |
Department of paediatrics
GMCH Aurangabad
GMCH Aurangabad
Maharashtra
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
|
| Fax |
|
| Email |
dr_prashantpatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PS Patil |
| Designation |
Head and professor, department of paediatrics |
| Affiliation |
GMCH Aurangabad |
| Address |
Department of paediatrics
GMCH Aurangabad
GMCH Aurangabad
Maharashtra
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
|
| Fax |
|
| Email |
dr_prashantpatil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Epilepsy clinic and ward 24 and 25 GMCH Aurangabad, Paediatric OPD GMCH Aurangabad |
|
|
Primary Sponsor
|
| Name |
Muhammed Shabeer P |
| Address |
Junior resident
Department of Paediatrics
GMCH Aurangabad |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 |
| Muhammed Shabeer P |
GMCH Aurangabad |
GMCH Aurangabad Padiatric Ward 24 and 25, Epilepsy Clinic , Paediatric OPD
Aurangabad
MAHARASHTRA |
9562028461
mohdshabeerp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Epilepsy, (1) ICD-10 Condition: G40||Epilepsy and recurrent seizures, (2) ICD-10 Condition: G404||Other generalized epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Other group revive antiepileptic agents |
| Intervention |
Vitamin E |
Vitamin E supplemented with anticonvulsant , antiepilectics which is needed for the child. Vitamin E according upper limit of RDA, for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age 1-12 years
Diagnosis of treatment resistant epilepsy
A) Recieving any of at least two anti convulsant drugs for past 6 months
B) at least 3 seizures in last 6 months
C) the ability of family or friends to count the number of seizures in epileptic patients during the determined period |
|
| ExclusionCriteria |
| Details |
Neuroimaging suggestive of mass lesion
Receiving vitamin E supplementation within 6 months of study
Presence of live and kidney disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study effect of Vitamin E supplementation in the reduction of seizure episodes in treatment resistant epilepsy patients on antiepileptuc drugs |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study seizure episode reduction in different types of seizure in Vitamin E supplemented children
To study correlation of vitamin E supplementation and reduction of seizure episodes with different antiepileptic drugs
To study side effects of vitamin E in supplemented group |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2018 |
| Date of Study Completion (India) |
30/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Vitamin E is a antioxidant , oxidative stress is important pathogen for epilepsy and many of anti epileptic drugs produces oxidative stress, so vitamin E can act here. Here Vitamin E is supplementing to treatment resistant epilepsy in addition to anticoagulant drugs for 6 months , study the outcomes like reduction in seizure episodes, relation with antiepileptic drugs and also side effects of vitamin E if any. EEG will be recorded before and after study. Study completed, concluded that Vitamin helpful in reducing the number seizure lasting more than 5 min ( impending status). No significant change in number seizure , EEG changes , antiepileptic drugs after supplementing vitamin E to children with treatment resistant epilepsy |