Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy

NCT03764956 | Unknown Phase 4

• 1 other identifier: IECPG/504/10/2018
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children

Conditions

Drug Resistant Epilepsy; Ketogenic Dieting

Keywords

MAD; LGIT

Outcome Measures

Primary Outcomes (1)

• Percentage of seizure reduction from baseline at 24 weeks of therapy

  Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100

  At the end of 24 weeks of dietary therapy

Secondary Outcomes (9)

• Proportion of children who achieve >50% seizure reduction

  At the end of 24 weeks of dietary therapy

• Incidence of adverse events

  At the end of 24 weeks of dietary therapy

• Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory

  At the end of 24 weeks of dietary therapy

• Change in Social quotient(SQ) with each dietary therapies

  At the end of 24 weeks of dietary therapy

• Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline

  At the end of 24 weeks of dietary therapy

Study Arms (2)

Low Glycemic Index therapy

EXPERIMENTAL

Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only

Other: Low glycemic Index Therapy (LGIT)

Modified Atkins Diet

ACTIVE COMPARATOR

Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio

Other: Modified Atkins Diet (MAD)

Interventions

Low glycemic Index Therapy (LGIT) OTHER

Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only. For this purpose, various dietary menus will be provided to the parents.

Low Glycemic Index therapy

Modified Atkins Diet (MAD) OTHER

Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio. For this purpose, various dietary menus will be provided to the parents.

Modified Atkins Diet

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1-15 years with drug resistant epilepsy
• Willing to come for regular follow-up according to study protocol Drug resistant epilepsy defined as
• Seizure frequency \>4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs
• For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin

You may not qualify if:

• Surgically remediable causes for DRE
• Inborn errors of metabolism
• Previously received KD, MAD or LGIT
• Known case of
• Chronic kidney disease
• Chronic liver disease/GI illness
• Congenital/acquired heart disease
• Chronic respiratory illness

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (2)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

AIIMS

New Delhi, National Capital Territory of Delhi, India

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sheffali Gulati, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati, MD

CONTACT

9810386847; sheffaligulati@gmail.com

Vaishakh Anand, MD

CONTACT

7838528549; drvyshakhanandmp@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief, Child Neurology Division

Model Details: Open label randomized non inferiority trial with two parallel arms

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: December 5, 2018
• Study Start: December 26, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

IN (2)