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Use of the Atkins Diet for Children With Sturge Weber Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00639730
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : May 27, 2010
Sponsor:
Collaborator:
Vascular Birthmarks Foundation
Information provided by:
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE March 14, 2008
First Posted Date  ICMJE March 20, 2008
Last Update Posted Date May 27, 2010
Study Start Date  ICMJE May 2006
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
Seizures [ Time Frame: 6 months ]
Seizure frequency will be compared to baseline (pre-Diet).
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
Seizure reduction [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
  • Ketosis [ Time Frame: 6 months ]
  • Safety (stroke like events) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of the Atkins Diet for Children With Sturge Weber Syndrome
Official Title  ICMJE Use of the Atkins Diet for Children With Sturge Weber Syndrome
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.

Detailed Description

If you agree to be in this study, we will ask you to do the following things:

Before the diet is started:

  • We will ask you to keep track of your child's seizures daily for 2 weeks before starting the Atkins diet and provide us with a 3-day food record as well.
  • Baseline blood (about 2 teaspoons) and urine work will be obtained.
  • We will give you a free copy of a carbohydrate-counting guide.
  • You will be asked to fill out a 3-day food record.

On the diet:

  • Give your child a daily calcium supplement and multivitamin.
  • Keep a daily seizure log.
  • Check urine for ketones (to make sure the diet is working) and specific gravity (to make sure your child is well hydrated) twice a week and when you come to clinic.
  • We will ask you to weigh your child at home every week, and we will weigh him or her when you come into clinic too.
  • Do not fluid restrict your child; please give plenty of carbohydrate-free fluids.
  • You will give 20 grams per day of carbohydrates. We will give you instructions on how to measure daily intake of carbohydrates.
  • We will not change medications for the first three months. Do not change your child's seizure medicines without checking with our doctors.
  • For the first three months, we ask you to avoid store-bought low-carbohydrate products (as they can have more carbohydrates than advertised).

After being on the diet for one month, Dr. Kossoff will contact you by telephone to discuss how your child is doing. You can also speak with one of our dietitians. We will discuss the 3-day food record with you

You will be asked to come to the clinic (outpatient center, 5th floor) for two follow-up visits:

  1. after being on the diet for 3 months and
  2. after being on the diet for 6 months.

During these visits you will meet with one of our doctors and a dietitian. We will review your child's seizure control and health. We may obtain blood (about 2 teaspoons). We will check your child's urine for ketones and specific gravity.

If the diet is helping beyond 6 months, we will help your child continue on the diet with clinic visits and labs as necessary, at a carbohydrate amount that is most helpful.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Sturge Weber Syndrome
Intervention  ICMJE Dietary Supplement: modified Atkins diet
High fat, low carbohydrate diet
Study Arms  ICMJE Experimental: A
This is open-label - all patients are placed on the diet. There is no control or placebo arm.
Intervention: Dietary Supplement: modified Atkins diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 14, 2008)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 2-18 years
  • Sturge Weber syndrome
  • Monthly seizures (at least)
  • Tried at least two anticonvulsants

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00639730
Other Study ID Numbers  ICMJE NA_00003359
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Kossoff MD, Johns Hopkins School of Medicine
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Vascular Birthmarks Foundation
Investigators  ICMJE
Principal Investigator: Eric H Kossoff, MD Johns Hopkins School of Medicine
PRS Account Johns Hopkins University
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP