EpilepsyPhase 4NCT00564915
RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
A Phase 4 study testing Ketogenic diet in people with Epilepsy, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Ketogenic diet
- How many people
- 145 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2001to Jul 2006
- Phase
- Phase 4
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Child Health, The Wolfson Centre
London, WC1N 1EH
About this study
A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.
- Conditions
- Epilepsy
- Being tested
- Ketogenic diet
- Keywords
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
Ketogenic diet
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in seizure frequency
Measured: 3 months
Secondary outcomes (1)
Tolerability and assessment of ketosis and growth
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 posted29 Nov 2007 (estimated)
- Study startDec 2001
- Study completionJul 2006
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 EpilepsyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Helen Cross, Professor, Principal investigator, UCL Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564915
- Sponsor's protocol ID
- 98NR04
- Status last verified
- Nov 2007
- First submitted
- 28 Nov 2007
- Last updated
- 29 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol. 2008 Jun;7(6):500-6. doi: 10.1016/S1474-4422(08)70092-9. Epub 2008 May 2.
PubMed 18456557
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
- ClinicalTrials.gov ID
- NCT00564915
- Acronym / sponsor ID
- 98NR04
- Conditions
- Epilepsy
- Keywords
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Dec 2001
- Study completion
- Jul 2006 (actual)
- First posted
- 29 Nov 2007 (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.
A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ketogenic dietKetogenic diet | Dietary supplement | – |
Primary outcome
Change in seizure frequency
Time frame: 3 months
1 secondary outcome
Tolerability and assessment of ketosis and growth
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 29 Nov 2007.
- Derived from this study: PubMed 18456557Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol. 2008 Jun;7(6):500-6. doi: 10.1016/S1474-4422(08)70092-9. Epub 2008 May 2.
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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.
Helen Cross, Professor principal investigator
UCL Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketogenic diet in people with Epilepsy, run by Institute of Child Health at 1 site in United Kingdom.
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 1 inclusion and 0 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 29 Nov 2007. 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 Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in seizure frequency (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 NCT00564915, 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 29 Nov 2007.