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Atkins Diet for Difficult-to-Control Headaches in Teenagers

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ClinicalTrials.gov Identifier: NCT00181064
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 2, 2009
Information provided by:
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Daily Headache Behavioral: Modified Atkins diet Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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.
Study Start Date : September 2005
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Intervention Details:
    Behavioral: Modified Atkins diet
    15 grams of carbohydrates per day - high fat diet

Primary Outcome Measures :
  1. Headaches [ Time Frame: 3 months ]

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

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

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

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

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

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

Keywords provided by Johns Hopkins University:

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