Clinical Trial: Dietary Therapy In Epilepsy Treatment (DIET-Trial): A Randomised Non Inferiority Trial Comparing KD, MAD & LGIT for Drug Resistant Epilepsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Ketogenic Diet, Modified Atkins Diet and Low Glycemic Index Therapy Diet Among Children With Drug Resistant Epilepsy: A Randomised Non-Inferiority Trial

Brief Summary:

This randomised trial is undertaken to assess whether MAD or LGIT is non-inferior to KD with regard to seizure control at twenty-four weeks among children with drug resistant epilepsy. The hypothesis of the study is that in 1 to 15-year-old children with drug resistant epilepsy, use of Modified Atkins Diet (MAD) or Low Glycemic Index Therapy (LGIT) as an add on to the ongoing anti-epileptic drugs would not be inferior to ketogenic diet by >15% in terms of seizure reduction from baseline seizure frequency at 24 weeks.

The primary outcome of the study is to determine the efficacy of MAD as compared to KD and LGIT as compared to KD for seizure reduction in drug resistant epilepsy following 24 weeks of dietary therapy in 1 to 15-year-old children on anti-epileptic drugs. The change in seizure frequency will be estimated as percentage change in seizure reduction at 24 weeks as compared to baseline.

Detailed Summary:
Sponsor: All India Institute of Medical Sciences, New Delhi

Current Primary Outcome: Percentage change in seizure frequency after 24 weeks of dietary therapy as compared to baseline, in the arm KD as compared to MAD and in the arm KD as compared to LGIT [ Time Frame: Baseline and six months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Percentage change in seizure frequency after 24 weeks of dietary therapy as compared to baseline, in the arm MAD as compared to LGIT [ Time Frame: Baseline and twenty-four weeks ]
  Percentage change in seizure frequency will be estimated as mean number of weekly seizures over preceding 4 weeks after 24 weeks of dietary therapy divided by mean number of weekly seizures over preceding 4 weeks at the baseline. Change in seizure frequency in MAD and LGIT arm will be compared
• Proportion of patients who achieve >50% seizure reduction from baseline at 24 weeks after diet initiation [ Time Frame: Baseline and twenty-four weeks ]
  Proportion of patients who achieve >50% seizure reduction from baseline at 24 weeks after diet initiation
• Estimate behavior change as measured by Childhood behavior checklist in each of three arms at baseline, 12 weeks and 24 weeks after dietary therapy [ Time Frame: Baseline, twelve weeks, and twenty-four weeks ]
• Estimate cognition change as assessed by Vineland Social Maturity Scale in each of three arms at baseline, 12 weeks and 24 weeks after dietary therapy [ Time Frame: Baseline and twenty-four weeks ]
• Evaluate GI adverse events (diarrhoea, constipation and vomiting) assessed by parental questionnaire in each of the three arms at baseline and six months after therapy [ Time Frame: Baseline and twenty-four weeks ]
• Evaluate change in serum levels of micronutrients by laboratory testing in each of three arms at baseline and six months after therapy [ Time Frame: Baseline and twenty-four weeks ]
  Micronutrients like copper, zinc, retinol and vitamin E would be compared
• Evaluate omega3 polyunsaturated fatty acid levels and correlate it with change in seizure frequency [ Time Frame: Baseline and twenty-four weeks ]

Original Secondary Outcome:

• Percentage change in seizure frequency after 24 weeks of dietary therapy as compared to baseline, in the arm MAD as compared to LGIT [ Time Frame: Baseline and twenty-four weeks ]
  Percentage change in seizure frequency will be estimated as mean number of weekly seizures over preceding 4 weeks after 24 weeks of dietary therapy divided by mean number of weekly seizures over preceding 4 weeks at the baseline. Change in seizure frequency in MAD and LGIT arm will be compared
• Proportion of patients who achieve >50% seizure reduction from baseline at 24 weeks after diet initiation [ Time Frame: Baseline and twenty-four weeks ]
  Proportion of patients who achieve >50% seizure reduction from baseline at 24 weeks after diet initiation
• Estimate behavior change as measured by Childhood behavior checklist in each of three arms at baseline, 12 weeks and 24 weeks after dietary therapy [ Time Frame: Baseline, twelve weeks, and twenty-four weeks ]
• Estimate cognition change as assessed by Vineland Social Maturity Scale in each of three arms at baseline, 12 weeks and 24 weeks after dietary therapy [ Time Frame: Baseline and twenty-four weeks ]
• Evaluate GI adverse events (diarrhoea, constipation and vomiting) assessed by parental questionnaire in each of the three arms at baseline and six months after therapy [ Time Frame: Baseline and twenty-four weeks ]
• Evaluate change in serum levels of copper, zinc, retinol and vitamin E by laboratory testing in each of three arms at baseline and six months after therapy [ Time Frame: Baseline and twenty-four weeks ]
• Evaluate omega3 polyunsaturated fatty acid levels and correlate it with change in seizure frequency [ Time Frame: Baseline and twenty-four weeks ]

Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: February 22, 2016
Date Started: April 2016
Date Completion: September 2016
Last Updated: July 10, 2016
Last Verified: July 2016