The modified Atkins diet in patients with refractory epilepsy and severe intellectual disability: a randomized controlled trial.

The modified Atkins diet in patients with refractory epilepsy and severe intellectual disability: a randomized controlled trial. - The modified Atkins diet in epilepsy: an RCT.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40609

Enrollment

Registered

2013-10-29

Start date

2014-01-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory epilepsy - Drug-resistant epilepsy

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)