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Atkins Diet for Difficult-to-Control Headaches in Teenagers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181064
First Posted: September 16, 2005
Last Update Posted: July 2, 2009
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.
Information provided by:
Johns Hopkins University
  Purpose
This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache improvement.

Condition Intervention Phase
Chronic Daily Headache Behavioral: Modified Atkins diet Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Atkins Diet for Adolescents With Chronic Daily Headache.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Headaches [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Ketosis [ Time Frame: 3 months ]
  • Diet duration [ Time Frame: as long as tolerated ]
  • Quality of life (PedsMIDAS) [ Time Frame: 3 months ]

Estimated Enrollment: 10
Study Start Date: September 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Modified Atkins diet
    15 grams of carbohydrates per day - high fat diet
Detailed Description:
Patients are placed on the diet and followed with various measures for 3 months. If the diet is helpful it is continued. Patients are still being enrolled as of 9/6/06.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 12-19
  • Minimum 15 headaches/month for at least 3 months
  • Tried 2 preventative medications previously

Exclusion Criteria:

  • Prior use of the Atkins diet for more than 1 week
  • Pregnancy
  • Significant heart or kidney disease
  • Dangerously underweight
  • Using acute pain medications more than 11 days in the past month
  • Medications being changed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181064


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Eric H Kossoff, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Eric Kossoff, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181064     History of Changes
Other Study ID Numbers: 05-08-10-04
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: July 2, 2009
Last Verified: June 2009

Keywords provided by Johns Hopkins University:
headache
Atkins
ketosis
intractable

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases