EpilepsyNCT01278966
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
A study testing The Modified Atkins Diet in people with Epilepsy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- The Modified Atkins Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- May 2009to Dec 2010
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age: 2-18 years
- At least 3 epileptic seizures per week
- Tried at least two anti-epileptic drugs without satisfactory seizure control
- Willing to try diet treatment for 6 months
Who cannot join
- Too difficult for the family to adhere to a strict diet
- Not able to fill in a seizure calendar
- Local authorities will not approve the treatment
- VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months
- Other disease where a diet high in fat is contra indicated
- Diet treatment is not possible because of poor intake of food or fluids
Show all 10Show fewer
- Cortisol or other medication that influence energy metabolism or epileptic drug metabolism last month
- Patient has the last month used alternative medicine which may influence the diet
- Patient has tried the ketogenic fiet og Modified Atkins diet the last three years
- pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
The National Centre for Child Epilepsy
Pb. 53, Bærum Postterminal, 1306
About this study
Official title: Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial
The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.
Read the detailed description
The study is a prospective trial on the Modified Atkins Diet for children and adolescents with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the classical ketogenic diet, which is usually offered to this group of patients. Twenty patients between 2 and 18 years are included in the study, and the study period is 6 months. The study will be conducted at the National Centre for Child Epilepsy in Norway.
- Conditions
- Epilepsy
- Being tested
- The Modified Atkins Diet
- Keywords
- Epilepsy, Diet, the Modified Atkins Diet, Ketogenic diet
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Modified Atkins DietOther
Also called Ketogenic diet
The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake
| Study group | Role | What they receive |
|---|---|---|
| The Modified Atkins Diet | Experimental | Treatment with the Modified Atkins Diet for 6 months Receives: Other: The Modified Atkins Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
Seizure frequency is assessed after 1 month, 3 months and 6 months.
Measured: 6 months
Secondary outcomes (5)
Ambulatory EEG
24-hours EEG before diet treatment and after 6 months on the diet.
Measured: After 6 months
Body Weight
Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.
Measured: 6 months
Quality of life
Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.
Measured: 6 months
Ketosis
Ketosis in blood and urine measured during the whole study period
Measured: 6 months
Dietary records
3-days dietary records were obtained after two and ten weeks on the diet.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Morten Lossius, Phd, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278966
- Sponsor's protocol ID
- S-09180a (REK)
- Status last verified
- Dec 2010
- First submitted
- 29 Dec 2010
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial
- ClinicalTrials.gov ID
- NCT01278966
- Acronym / sponsor ID
- S-09180a (REK)
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Diet, the Modified Atkins Diet, Ketogenic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jan 2011 (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.
The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.
Detailed description
The study is a prospective trial on the Modified Atkins Diet for children and adolescents with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the classical ketogenic diet, which is usually offered to this group of patients. Twenty patients between 2 and 18 years are included in the study, and the study period is 6 months. The study will be conducted at the National Centre for Child Epilepsy in Norway.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Modified Atkins Diet | Experimental | Other: The Modified Atkins DietTreatment with the Modified Atkins Diet for 6 months |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age: 2-18 years
- At least 3 epileptic seizures per week
- Tried at least two anti-epileptic drugs without satisfactory seizure control
- Willing to try diet treatment for 6 months
Key exclusion criteria (10 listed)
- Too difficult for the family to adhere to a strict diet
- Not able to fill in a seizure calendar
- Local authorities will not approve the treatment
- VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months
- Other disease where a diet high in fat is contra indicated
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 |
|---|---|---|
| The Modified Atkins DietAlso: Ketogenic dietThe Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake | Other | The Modified Atkins Diet |
Primary outcome
Seizure frequency
Time frame: 6 months
Seizure frequency is assessed after 1 month, 3 months and 6 months.
5 secondary outcomes
Ambulatory EEG
Time frame: After 6 months
Body Weight
Time frame: 6 months
Quality of life
Time frame: 6 months
Ketosis
Time frame: 6 months
Dietary records
Time frame: 10 weeks
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 19 Jan 2011.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
Morten Lossius, Phd study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Modified Atkins Diet in people with Epilepsy, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 10 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 19 Jan 2011. 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 Norway. 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.
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?
Seizure frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2011.