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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014