Health Condition 1: G939- Disorder of brain, unspecified Health Condition 2: null- Drug Resistant Epilepsy
Conditions
Interventions
Intervention1: Experimental Arm:Modified Atkins Arm
Control Arm: No Dietary Intervention: Experimental Arm: Diet will be stared after 4 weeks baseline period,during which daily seizure log will be mai
Sponsors
Indian Council Of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 10 -19yrs years and adults >19yrs- 55 years with drug resistant epilepsy (DRE). 2. Persisting, daily countable seizure (more than 2/month for 6 months). 3. Willing to come for regular follow up and able to note seizure frequency accurately. 4. Patients need to be willing to perform the induction phase of the Diet. â??DREâ??: More than 2 seizures per month for 6 months or more, on at least 3 appropriate AEDs at their maximum tolerated doses, with any one of them being a newer AED.
Exclusion criteria
Exclusion criteria: 1. 2. Surgically remediable cause for resistant epilepsy. 3. Clinical features of inborn errors of metabolism. 4. Clinical suspicion of metabolic disorder, Systemic disease-Diabetes Mellitus, Cardiovascular Disease, metabolic disease or prior Myocardial infarction. 5. Two or more the following abnormalities: a. High blood ammonia( >80mmol/L) b. High arterial lactate( >2mmol/L) c. Metabolic acidosis(Ph >7.2) d. Hypoglycemia(blood sugar 6. Refusal to give consent. 7. Patients who had tried Ketogenic diet within the past 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patients who achieve 50 percent seizure reduction in Seizure frequency in MAD at 6 months after initiation of diet therapyTimepoint: 6 months of diet initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate and characteristics of short term adverse events while on MAD. 2. Rate of withdrawal from the MAD diet during the study period and reasons for withdrawal. 3. Change in Quality of life using QOLIE-31 and QOLIE-AD-48 scale and behavior using CBCL and ABCL) in both the groups. Timepoint: F/U at 6 months after diet initiation | — |
Countries
India
Contacts
Public ContactMala Manral
AIIMS
Outcome results
None listed