Atkins Diet for Difficult-to-Control Headaches in Teenagers | NCT00181064

Studies
Atkins Diet for Difficult-to-Control Headaches in Teenagers

NCT00181064

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Jul 2, 2009Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Chronic Daily Headache

Interventions

Modified Atkins diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2009

Last Update Posted Date

Jul 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Modified Atkins diet	Behavioral	15 grams of carbohydrates per day - high fat diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Headaches		3 months

Secondary Outcomes

Measure	Description	Time Frame
Ketosis		3 months
Diet duration		as long as tolerated
Quality of life (PedsMIDAS)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric H Kossoff, MD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21287	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16412174	Background	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.

ID	Term
D020773	Headache Disorders
D006261	Headache
D007662	Ketosis

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D010146	Pain