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Atkins Diet for Difficult-to-Control Headaches in Teenagers

Primary Purpose

Chronic Daily Headache

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Modified Atkins diet

About this trial

This is an interventional treatment trial for Chronic Daily Headache focused on measuring headache, Atkins, ketosis, intractable

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins Hospital

Outcomes

Primary Outcome Measures

Headaches

Secondary Outcome Measures

Ketosis

Diet duration

Quality of life (PedsMIDAS)

Full Information

NCT ID

NCT00181064

First Posted

September 9, 2005

Last Updated

July 1, 2009

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT00181064

Brief Title

Atkins Diet for Difficult-to-Control Headaches in Teenagers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Daily Headache

Keywords

headache, Atkins, ketosis, intractable

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Modified Atkins diet

Intervention Description

15 grams of carbohydrates per day - high fat diet

Primary Outcome Measure Information:

Title

Headaches

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Ketosis

Time Frame

3 months

Title

Diet duration

Time Frame

as long as tolerated

Title

Quality of life (PedsMIDAS)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric H Kossoff, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16412174

Citation

Strahlman RS. Can ketosis help migraine sufferers? A case report. Headache. 2006 Jan;46(1):182. doi: 10.1111/j.1526-4610.2006.00321_5.x. No abstract available.

Results Reference

background

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Atkins Diet for Difficult-to-Control Headaches in Teenagers

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