Expired Study
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Baltimore, Maryland 21287


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

05-08-10-04


NCT ID:

NCT00181064


Secondary ID:


Study Acronym:


Brief Title:

Atkins Diet for Difficult-to-Control Headaches in Teenagers


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Eric H Kossoff, MD
Principal Investigator
Johns Hopkins University

Study Dates

Start Date:September 2005
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:July 1, 2009
First Received Date:September 9, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quality of life (PedsMIDAS)
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Diet duration
Time Frame:as long as tolerated
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Ketosis
Time Frame:3 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Headaches
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Modified Atkins diet
Description:15 grams of carbohydrates per day - high fat diet

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Strahlman RS. Can ketosis help migraine sufferers? A case report. Headache. 2006 Jan;46(1):182. No abstract available.
PMID:16412174

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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