EpilepsyNCT00188500
Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy
A study testing atkins diet and ability to follow low carbohydrate diet in people with Epilepsy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether patients with uncontrolled epilepsy can follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- atkins diet and ability to follow low carbohydrate diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Sep 2005
- Phase
- Interventional
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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Low BMI
Trial locations and contacts
1 site in 1 country.
Nina Politzer contact
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Nina Politzer, BScN, 416 603-5800 ext. 2446, politzer@uhnres.utoronto.ca
J. Martin delCampo, MD FRCP(C)
About this study
Official title: Efficacy, Tolerability and Long-Term Adherence of a Modified Ketogenic Diet (Atkins) in the Management of Pharmacoresistant Epilepsy
The purpose of this study is to determine whether patients with uncontrolled epilepsy can follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures
Read the detailed description
In the management of drug-resistant epilepsy, many strategies have been examined. The Ketogenic Diet, high in fats and low in all other nutrients was observed to be of benefit. However, due to its complexedness and unpalatability, this diet is rarely used in the adult population. A recent small study showed seizure reduction with the Atkins Diet.
In this study, patients will be randomized into one of 2 groups- group 1 receiving limited dietary instruction for the Atkins Diet and group 2- receiving detailed dietary instruction. A seizure severity-matched control group will also take part. We will follow these patients over a period of 2 years looking at seizure frequency, weight, sustainability of the diet, effect on anti-epilepsy medication dosage, effect in cognition, quality of life and financial impact of the diet.
Patients will come to clinic to see the dietitian at specific intervals. cognitive testing will also be done at the beginning of the study and every 6 months thereafter. Patients will keep food charts, ketosis charts and seizure diaries.
- Conditions
- Epilepsy
- Being tested
- atkins diet, ability to follow low carbohydrate diet
- Keywords
- epilepsy, atkins diet
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atkins dietBehavioural
ability to follow low carbohydrate dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure reduction
Secondary outcomes (1)
cognitive improvement
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 startAug 2005
- Study completionSep 2005
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 University Health Network, TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- J Martin delCampo, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188500
- Sponsor's protocol ID
- 05-0027-AE
- Status last verified
- Mar 2004
- First submitted
- 12 Sep 2005
- Last updated
- 29 Dec 2005
- Results posted
- No