Atkins Diet for Difficult-to-Control Headaches in Teenagers
July 1, 2009 updated by: Johns Hopkins University
Use of the Atkins Diet for Adolescents With Chronic Daily Headache.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 19 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Headaches
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ketosis
Time Frame: 3 months
|
3 months
|
|
Diet duration
Time Frame: as long as tolerated
|
as long as tolerated
|
|
Quality of life (PedsMIDAS)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (ESTIMATE)
September 16, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
July 2, 2009
Last Update Submitted That Met QC Criteria
July 1, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-08-10-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.