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Completed

NCT Number: NCT00181090

Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits

This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution. In this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.

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Key information

Conditions

Epilepsy Acid-Base Imbalance Acidosis Brain Diseases Central Nervous System Diseases Ketosis Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 3-18
  • Daily seizures or 7 per week
  • Failed at least 2 anticonvulsants

Exclusion criteria

  • Prior use of the Atkins diet for over 1 week
  • Significant heart, liver, or kidney disease

Treatment and study plan

Modified Atkins Diet

Behavioral

Primary outcomes

  1. Seizure control

    Time frame: 6 months

  2. Ketosis

    Time frame: 6 months

Secondary outcomes

  1. Tolerability

    Time frame: 6 months

  2. Safety - cholesterol, kidney function, weight

    Time frame: 6 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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