Use of the Atkins Diet for Children With Sturge Weber Syndrome

NCT00639730 | Completed Phase 1 DMC

• 1 other identifier: NA_00003359
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to find out if the Atkins Diet can be used safely and effectively to reduce seizures in children who have Sturge Weber syndrome. The ketogenic diet is a proven therapy for epilepsy, but can be difficult to use in children. The Atkins Diet is a high fat, high protein, low carbohydrate diet introduced in the 1970s to help with weight loss. It is different from the ketogenic diet in four major ways: no calorie restriction, no fluid restriction, no protein restriction, and is easy to start outside the hospital. People on the Atkins Diet become ketotic (produce high levels of ketones, a certain substance in the body), like patients on the ketogenic diet, and the investigators believe this may lead to seizure control. Children aged 2-18 with Sturge Weber syndrome and seizures at least monthly, who have used at least two anti-seizure drugs may join. 5 children in total will be enrolled.

Conditions

Epilepsy; Sturge Weber Syndrome

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Seizures

  Seizure frequency will be compared to baseline (pre-Diet).

  6 months

Secondary Outcomes (2)

• Ketosis

  6 months

• Safety (stroke like events)

  6 months

Study Arms (1)

A

EXPERIMENTAL

This is open-label - all patients are placed on the diet. There is no control or placebo arm.

Dietary Supplement: modified Atkins diet

Interventions

modified Atkins diet DIETARY_SUPPLEMENT

High fat, low carbohydrate diet

A

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years
• Sturge Weber syndrome
• Monthly seizures (at least)
• Tried at least two anticonvulsants

You may not qualify if:

• Prior use of the Atkins or ketogenic diets
• Patients with non-epileptic seizures (pseudoseizures) will be excluded
• Patients that are pregnant or become pregnant during the study will be excluded
• High cholesterol

Sponsors & Collaborators

• Johns Hopkins University: lead
• Vascular Birthmarks Foundation: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Kossoff EH, Turner Z, Bluml RM, Pyzik PL, Vining EP. A randomized, crossover comparison of daily carbohydrate limits using the modified Atkins diet. Epilepsy Behav. 2007 May;10(3):432-6. doi: 10.1016/j.yebeh.2007.01.012. Epub 2007 Feb 26.

  PMID: 17324628 BACKGROUND

• Kossoff EH, McGrogan JR, Bluml RM, Pillas DJ, Rubenstein JE, Vining EP. A modified Atkins diet is effective for the treatment of intractable pediatric epilepsy. Epilepsia. 2006 Feb;47(2):421-4. doi: 10.1111/j.1528-1167.2006.00438.x.

  PMID: 16499770 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Sturge-Weber Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Neurocutaneous Syndromes; Angiomatosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eric H Kossoff, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: May 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 27, 2010

Record last verified: 2010-05

Locations

US (1)