Atkins Diet for Difficult-to-Control Headaches in Teenagers

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181064
First received: September 9, 2005
Last updated: July 1, 2009
Last verified: June 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ketosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Diet duration [ Time Frame: as long as tolerated ] [ Designated as safety issue: No ]
  • Quality of life (PedsMIDAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 9, 2005
Last Updated: July 1, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014