Chronic Daily HeadachePhase 1NCT00181064
Atkins Diet for Difficult-to-Control Headaches in Teenagers
A Phase 1 study testing Modified Atkins diet in people with Chronic Daily Headache, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Chronic Daily Headache
- What is being tested?
- Modified Atkins diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 12-19
- Minimum 15 headaches/month for at least 3 months
- Tried 2 preventative medications previously
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Atkins Diet for Adolescents With Chronic Daily Headache.
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.
Read the 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.
- Conditions
- Chronic Daily Headache
- Being tested
- Modified Atkins diet
- Keywords
- headache, Atkins, ketosis, intractable
- Medical subject headings
- Headache Disorders, Headache, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins dietBehavioural
15 grams of carbohydrates per day - high fat diet
What is being measured
The primary outcome is the main question the study is designed to answer.
Headaches
Measured: 3 months
Secondary outcomes (3)
Ketosis
Measured: 3 months
Diet duration
Measured: as long as tolerated
Quality of life (PedsMIDAS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Daily HeadacheStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Eric H Kossoff, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181064
- Sponsor's protocol ID
- 05-08-10-04
- Status last verified
- Jun 2009
- First submitted
- 9 Sep 2005
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16412174
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Atkins Diet for Adolescents With Chronic Daily Headache.
- ClinicalTrials.gov ID
- NCT00181064
- Acronym / sponsor ID
- 05-08-10-04
- Conditions
- Chronic Daily Headache
- Keywords
- headache, Atkins, ketosis, intractable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Ages 12-19
- Minimum 15 headaches/month for at least 3 months
- Tried 2 preventative medications previously
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Atkins diet15 grams of carbohydrates per day - high fat diet | Behavioural | – |
Primary outcome
Headaches
Time frame: 3 months
3 secondary outcomes
Ketosis
Time frame: 3 months
Diet duration
Time frame: as long as tolerated
Quality of life (PedsMIDAS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
- Background: PubMed 16412174Strahlman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric H Kossoff, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Modified Atkins diet in people with Chronic Daily Headache, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headaches (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00181064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2009.