NCT03764956

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

Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current treatment options for DRE include epileptic surgery and dietary therapy. Classic KD (Ketogenic diet) is the most studied dietary therapy but the stringent restrictions and practical difficulty makes it difficult to follow. So less restrictive diets like MAD and LGIT were introduced. These are reported to have less adverse effects also. But no published study has ever been conducted comparing these two diets head to head.

Conditions

• Drug Resistant Epilepsy
• Ketogenic Dieting

Interventions

Type	Name	Description
OTHER	Low glycemic Index Therapy (LGIT)	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.
OTHER	Modified Atkins Diet (MAD)	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.

Timeline

• Start date: 2018-12-26
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-12-05
• Last updated: 2019-09-10

Locations

2 sites across 1 country: India