| CTRI Number |
CTRI/2024/05/067973 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional Supplementation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of an Indigenous Ketogenic Formula and Determination of its Efficacy, Safety and Tolerability in improving Seizure Outcome among Children with Drug Resistant Epilepsy |
|
Scientific Title of Study
|
Development of an Indigenous Ketogenic Formula and Determination of its Efficacy, Safety and Tolerability in improving Seizure Outcome among A Cohort of Children with Drug Resistant Epilepsy in Tertiary Care Setting |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soma Basu |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Clinical Nutrition, Sri Ramachandra Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9630296456 |
| Fax |
|
| Email |
somabasu@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AJ Hemamalini |
| Designation |
Professor and Head, Department of Clinical Nutrition |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Clinical Nutrition, Sri Ramachandra Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841327708 |
| Fax |
|
| Email |
hemamalini.aj@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr AJ Hemamalini |
| Designation |
Professor and Head, Department of Clinical Nutrition |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Clinical Nutrition, Sri Ramachandra Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841327708 |
| Fax |
|
| Email |
hemamalini.aj@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India - 600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India |
| Address |
No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ranjith Kumar Manokaran |
Sri Ramachandra Institute of Higher Education and Research |
Department of Neurology, Division of Pediatric Neurology and Epileptology, Room Number - 25, No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9013860064
doct.ranjith@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Children with Epilepsy (1month – 5 years) who are not controlled on anti seizure medications and those who are not willing for Epilepsy Surgery. |
Duration of Supplementation - 4 months,
Duration of Follow up - 6 months.
Nutrition Intervention will be provided by introducing non fasting Ketogenic Diet protocol to the study participants with close monitoring of urine ketones levels using Keto-Diastix. Also individualized Ketogenic Diets will be planned based on patient need and requirement and Developed Indigenous Ketogenic Formula will be supplemented for 4 months to the patient who are on NG feed as well as on oral diet. Participants will be followed up for 6 months to see the efficacy, safety and tolerability of Ketogenic Diet.
Since ketogenic diet forms an integral aspect of the treatment protocol for all children with Drug Resistant Epilepsy. Consequently, its imperative that no patient is left untreated. Therefore, to facilitate result comparison, we will gather data on seizure frequency both at baseline, prior to commencing the ketogenic diet, and at the end line, subsequent to initiating the diet. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children with Epilepsy (1month – 5 years) who are not controlled on anti seizure medications and those who are not willing for Epilepsy Surgery. |
|
| ExclusionCriteria |
| Details |
Children with certain metabolic disorders such as defects in fatty acid oxidation, carnitine deficiency, and certain organic acidemias or those with history of pancreatitis, pre-existing liver conditions, gastrointestinal disorders and critically ill patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To develop indigenous, low cost and effective MCT based ketogenic formula which can be given orally as well as through NG feed.
2. To determine the efficacy of MCT based Ketogenic Diet in reducing the number of seizure episodes, achieving optimal ketosis and improving the urine ketone levels.
3. To determine the compliance, safety and tolerability of MCT based ketogenic diet by checking for any possible side effects.
|
6 months (For each child after 6 months of enrollment in the study primary outcome will be measured). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim –
v To
reduce the number of seizure episodes and to improve the urine ketone levels in
children with Drug Resistant Epilepsy and those who are not willing for
Epilepsy Surgery.
Study Objectives –
v To
develop indigenous, low cost and effective MCT based ketogenic formula which
can be given orally as well as through NG feed.
v To
determine the efficacy of MCT based Ketogenic Diet in reducing the number of
seizure episodes, achieving optimal ketosis and improving the urine ketone
levels.
v To
determine the compliance, safety and tolerability of MCT based ketogenic diet
by checking for any possible side effects.
Need for the Study
- Evidence suggests that Ketogenic Diet and its variants are a good option for
non-surgical pharmacoresistant patients with epilepsy. Studies have found that
LDL cholesterol levels might get elevated in some patients following ketogenic
diet. Studies have found MCTs have a
role in improving lipid profiles in dyslipidemia conditions, namely by
increasing HDL levels and lowering TG, total cholesterol, and LDL levels. Currently available Keto formulas are
expensive and not affordable at a longer duration by patients/family. Therefore, there is a need to develop MCT
based indigenous ketogenic formula which can be given orally as well as through
tube feeding and which is cost effective, made up of natural ingredients,
nutritious, effective and at same time can be acceptable by the patients. From the literature survey, it can be
concluded that MCT based ketogenic diet plays a very important role and found
to be effective in controlling seizure episodes among epileptic children. Also,
very few studies have been conducted in India to show the effectiveness of
ketogenic diet in treating childhood epilepsy. Thus, there is a need to study
the efficacy, safety and tolerability of MCT based ketogenic diet by developing
a MCT based Ketogenic Formula and supplementing it among Children with Epilepsy
who are not controlled on antiseizure medications and those who are not
amenable to surgery. |