| CTRI Number |
CTRI/2024/06/068371 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Modified Atkins diet in patients with drug refractory epilepsy on standard medical therapy |
|
Scientific Title of Study
|
Efficacy and tolerability of Modified Atkins diet in drug refractory epilepsy among adolescents and adults |
| 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 Victo Varghese |
| Designation |
Senior resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Room no 11,
Department of Neurology,
Block A, Ground floor,
Nehru building, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09074523882 |
| Fax |
|
| Email |
victo11421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parampreet S Kharbanda |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Room no 11,
Department of Neurology,
Ground floor, Block A,
Nehru Building,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
neuroparam@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parampreet S Kharbanda |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Room no 11,
Department of Neurology,
Ground floor, Block A,
Nehru Building,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
neuroparam@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Victo Varghese |
| Address |
Room no 11,
Department of Neurology,
Block A, Ground floor,
Nehru building, PGIMER, Chandigarh
160012 |
| Type of Sponsor |
Other [Self] |
|
|
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 Victo Varghese |
Postgraduate Institute of Medical Education and Research |
Room no 11,
Department of Neurology,
Block A, Ground floor,
Nehru building
Chandigarh
CHANDIGARH |
09074523882
victo11421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER,Chandigarh, Institutional Ethics Comittee(intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Atkins diet, Standard medical therapy |
3 months duration,
Frequency of dietary intervention - All meals patient take during study period,
Total carbohydrate content of 15-20 grams is allowed per day.
Required total calories is calculated as per body weight and given as 20 grams of carbohydrate/day, rest as fats and proteins. No water restriction is applied. |
| Comparator Agent |
Standard medical therapy |
3 months duration |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Drug refractory epilepsy (as per ILAE definition)
Patients who agree for regular follow up and ready to maintain seizure diary |
|
| ExclusionCriteria |
| Details |
Previous dietary intervention
Medical illness incompatible with intervention
Pregnant or lactating woman
Patients being evaluated for epilepsy surgery
Clinical suspicion of inborn errors of metabolism
Patients who defer consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Seizure frequency
Adverse effects of diet
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality Of Life In Epilepsy - Problems (QOLIE 10 P) Index |
3 months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
17/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/06/2024 |
| 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 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 is a randomized, open labelled, parallel group, single center trial comparing the efficacy and tolerability of Modified Atkins diet combined with standard medical therapy versus standard medical therapy for 3 months among 62 (31+31)adolescents and adults with drug refractory epilepsy. Primary outcome is measured in terms of seizure frequency, Side effects of dietary therapy, Quality of life in epilepsy-problems(QOLIE-P) Index at 3 months. |