Atkins Diet for Difficult-to-Control Headaches in Teenagers - Full Text View

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181064

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 I

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:

MedlinePlus related topics: Headache

U.S. FDA Resources

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:

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:

Strahlman RS. Can ketosis help migraine sufferers? A case report. Headache. 2006 Jan;46(1):182. No abstract available.

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 February 12, 2012