Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet

NCT03464487 | Unknown DMC

• 1 other identifier: Daily vs Intermittent LGIT
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.

Conditions

Drug Resistant Epilepsy

Outcome Measures

Primary Outcomes (1)

• Percentage of seizure reduction from baseline at 24 weeks in each arm

  Percentage of seizure reduction from baseline at 24 weeks in each arm will be calculated from Daily Seizure Log maintained by parents Percentage of seizure reduction at 24 weeks=x-y/x X 100 Y=Mean daily seizures at 24 weeks as measured over past 4 weeks X=Mean daily seizures at baseline as measured over 4 weeks Seizure log will contain details of number, duration and type of seizures as recorded by parents

  Percentage seizure reduction will be calculated for each child in each arm after 24 weeks follow up period is completed and finally mean seizure reduction in each arm will be computed at the end of 24 weeks

Secondary Outcomes (6)

• Proportion of patients with >50% seizure reduction in each dietary arm

  At the end of 24 weeks, it will be determined the proportion of children in each arm with >50% reduction in seizure frequency.

• Change in social quotient with each dietary therapy

  Vineland Social Maturity Scale will be done for each child at baseline and at 24 weeks to calculate social quotient at baseline and 24 weeks

• Proportion of patients with different clinical adverse events in each group

  Each child will be monitored for adverse effects clinically at 12 weeks and 24 weeks

• Correlate seizure frequency change at 24 weeks with blood HbA1c levels

  Absolute level of HbA1c levels (in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed

• Correlate seizure frequency change at 24 weeks with blood betahydroxy butyrate levels levels

  Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed

Study Arms (2)

Daily LGIT

ACTIVE COMPARATOR

The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy diet everyday along with the antiepileptic drugs.

Dietary Supplement: Low Glycemic Index Therapy Diet

Intermittent LGIT

ACTIVE COMPARATOR

The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy Diet on five days of each week along with antiepileptic drugs. Rest of the two days, they will receive a liberal diet.

Dietary Supplement: Low Glycemic Index Therapy Diet

Interventions

Low Glycemic Index Therapy Diet DIETARY_SUPPLEMENT

Low Glycemic Index Therapy Diet allows only carbohydrates with Glycemic Index less than 50 and also restricts daily carbohydrate intake to less than 40-60 gram per day.

Daily LGIT; Intermittent LGIT

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

You may not qualify if:

• Surgically remediable cause for drug resistant epilepsy
• Proven in born error of metabolism except in which dietary therapy for epilepsy is indicated(i.e. pyruvate carboxylase deficiency and GLUT 1 deficiency)
• Previously received KD, MAD or LGIT
• Known case of
• Chronic kidney disease
• Chronic liver disease/GI illness
• Chronic heart disease(congenital and acquired)
• Chronic respiratory illness

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

AIIMS

New Delhi, National Capital Territory of Delhi, India

RECRUITING

Related Publications (1)

• Panda PK, Chakrabarty B, Jauhari P, Sharawat IK, Agarwal A, Jain V, Pandey RM, Gulati S. Efficacy of daily versus intermittent low glycemic index therapy diet in children with drug-resistant epilepsy: A randomized controlled trial. Epilepsy Res. 2024 Mar;201:107322. doi: 10.1016/j.eplepsyres.2024.107322. Epub 2024 Feb 15.

  PMID: 38402708 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Sheffali Gulati, M.D.

  AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati, M.D.

CONTACT

26594679; sheffaligulati@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Child Neurology Division, Department of Pediatrics, AIIMS, New Delhi

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: March 14, 2018
• Study Start: February 15, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

IN (1)