Atkins Diet for Difficult-to-Control Headaches in Teenagers - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

July 1, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Headaches [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Quality of life
Headache frequency

Change History

Complete list of historical versions of study NCT00181064 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Ketosis
Diet duration

Descriptive Information

Brief Title ^ICMJE

Atkins Diet for Difficult-to-Control Headaches in Teenagers

Official Title ^ICMJE

Use of the Atkins Diet for Adolescents With Chronic Daily Headache.

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.

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Daily Headache

Intervention ^ICMJE

Behavioral: Modified Atkins diet

Study Arms / Comparison Groups

Publications *

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

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 19 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00181064

Responsible Party

Eric Kossoff, Johns Hopkins University

Study ID Numbers ^ICMJE

05-08-10-04

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Eric H Kossoff, MD

Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP