Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy

NCT ID: NCT02100501

Last Updated: 2015-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-03-31

Brief Summary

The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Atkins diet group

pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 53. enrolled patients are assigned to randomly in one of KD group or Atkins group.

No interventions assigned to this group

Ketogenic diet group

pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 51. enrolled patients are assigned to randomly in one of KD group or Atkins group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.

Exclusion Criteria

• Patients heve been tried KD or MAD before.
• Patients with renal stones, hyperlipidemia, cardiologic problems.
• Other conditions not adjust for dietary therapy.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoon-Chul Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Children's Hospital, Yonsei University college of medicine.

Locations

Severance Hospital

Seoul, Seodaemun-gu, South Korea

Countries

South Korea

References

Kim JA, Yoon JR, Lee EJ, Lee JS, Kim JT, Kim HD, Kang HC. Efficacy of the classic ketogenic and the modified Atkins diets in refractory childhood epilepsy. Epilepsia. 2016 Jan;57(1):51-8. doi: 10.1111/epi.13256. Epub 2015 Dec 10.

Reference Type: DERIVED

PMID: 26662710 (View on PubMed)

Other Identifiers

4-2011-0003

Identifier Type: -

Identifier Source: org_study_id