Atkins Diet for Difficult-to-Control Headaches in Teenagers

Phase 1

Completed

• Conditions: Chronic Daily Headache

• Registration Number: NCT00181064
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-07-01
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Headaches	3 months

Secondary Outcome Measures

Name	Time	Method
Ketosis	3 months
Diet duration	as long as tolerated
Quality of life (PedsMIDAS)	3 months

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States