Atkins Diet for Difficult-to-Control Headaches in Teenagers

Chronic Daily Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181064
• Other study ID #: 05-08-10-04
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: July 1, 2009
• Start date: September 2005
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Daily Headache
• Headache
• Headache Disorders

Intervention

Behavioral:
• Modified Atkins diet
15 grams of carbohydrates per day - high fat diet

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Strahlman RS. Can ketosis help migraine sufferers? A case report. Headache. 2006 Jan;46(1):182. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headaches		3 months	No
Secondary	Ketosis		3 months	No
Secondary	Diet duration		as long as tolerated	No
Secondary	Quality of life (PedsMIDAS)		3 months	No