The main objective is to evaluate the effect of the modified Atkins diet on the seizure frequency of institutionalized adults with refractory epilepsy and severe intellectual disability.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To analyse the efficacy of the Modified Atkins diet (MAD), defined as 50%
reduction in seizure frequency at 4 months, compared to a control group.
Secondary outcome
The secondary objectives are:
• To analyse retention rate of the MAD in this population, as a measure of
overall effectiveness;
• To analyse the efficacy of the MAD, defined as improvement of daily
functioning, studied with the Habilitative Improvement Scale (HIS);
• To assess the feasibility of the MAD in this population and this setting,
with respect to logistics and adherence;
• To assess (serious) adverse events attributable to the MAD;
• To analyse which factors are associated with efficacy of the diet.
Background summary
Epilepsy is one of the most common chronic neurological disorders. It affects
approximately 14-44% of the people with intellectual disabilities (ID) and
depending on the underlying etiology of the ID, the prevalence can be as high
as 66%. Of all patients with epilepsy, approximately 30% will continue to have
seizures and thus remain refractory to medical treatments. In patients with
intellectual disability, this number is probably higher.
In children with refractory epilepsy, a beneficial effect of the ketogenic diet
has been demonstrated. In adolescents and adults the ketogenic diet is less
often used due to expected non- compliance to this very restricted diet. The
last ten years, studies have been published evaluating the effect of the
Modified Atkins diet (MAD) - a less restricted form of the ketogenic diet - on
the seizure frequency in children and adults with refractory epilepsy. These
studies showed a high tolerability and efficacy of the modified Atkins diet on
seizure control in drug resistant epilepsy. So far, data on efficacy of the MAD
in adult patients with ID and refractory epilepsy is lacking. We expect that,
in this population the MAD will have a beneficial effect in reducing seizure
frequency as well.
Study objective
The main objective is to evaluate the effect of the modified Atkins diet on the
seizure frequency of institutionalized adults with refractory epilepsy and
severe intellectual disability.
Study design
This study will be a prospective open-label randomized controlled trial.
Intervention
The intervention group will be treated with the MAD for at least 4 months, with
a total follow-up of at least 6 months. After the 4-month trial period, the
control group can be started on the MAD as well.
Study burden and risks
The MAD is a less strict form of the ketogenic diet, a well-known and
worldwide-implemented treatment for refractory epilepsy in children. Based on
current findings in literature the MAD appears to be well tolerable with
minimal side effects. This proposed study is therefore considered a low-risk
study. The burden for the patients and caregivers will be kept to a minimum.
The burden for the caregivers and legal representatives include strict keeping
of a seizure dairy, not different from everyday clinical practice in the
institution, monitoring side effects, weekly monitoring of ketosis and weight
and filling in the HIS questionnaires after the run-in period and the 4 month
trial period.
The burden for patients includes adherence to the diet regime and laboratory
investigations, which will be kept to a minimum. Patients will be monitored
carefully for any possible side effects.
Nieuwenoordlaan 12
Baarn 3744PA
NL
Nieuwenoordlaan 12
Baarn 3744PA
NL
Listed location countries
Age
Inclusion criteria
• Age > 18 years, moderate to severe ID;
• Refractory epilepsy, defined as failure of two tolerated and appropriately chosen and used AED schedules;
• More than two seizures per month, which are judged by the carers and the treating physician to impose a significant impact on the patients* QOL --justifying treatment;
• Informed consent obtained by at least one legal representative;
Exclusion criteria
• Undergone epilepsy surgery in the last 6 months, or awaiting pre-surgical evaluation;
• Underwent implantation of a vagal nerve stimulation in the last 6 months;
• Previous use of the MAD or the KD for more than 7 days in the last year prior to inclusion;
• Hypercholesterolemia (total cholesterol >8), cardiovascular disease or kidney failure, metabolic disorders known to deteriorate after fasting;
• Severe underweight, defined as a BMI < 16.5;
• Diabetes Mellitus.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44058.041.13 |