Hulshof 2014.

Trial name or title	The modified Atkins diet in patients with drug‐resistant epilepsy and severe intellectual disability ‐ design of a randomized controlled trial
Methods	A single‐centre, parallel, unblinded randomised controlled trial
Participants	Aimed to recruit 54 people, aged > 18 years, adults with drug‐resistant epilepsy that was controlled by 2 AEDs. Included participants must have had ≥ 2 seizures/month and have moderate‐to‐severe intellectual disability. Potential participants were excluded if they had undergone epilepsy surgery in the last 6 months or were awaiting surgery; underwent implantation of vagal nerve stimulation in the last 6 months; have used the MAD or KD for > 7 days in the last year
Interventions	Intervention group treated with the MAD for at least 4 months, with a total follow‐up of at least 6 months Control group comprised a waiting list in which participants can begin the MAD diet after the 4‐month trial period, the control group can be started on the MAD as well, in which efficacy, tolerability and safety will also be evaluated
Outcomes	Primary outcome Number of responders 4 months after randomisation, compared between the intervention and the control group. Responder is defined by > 50% reduction in seizure frequency Secondary outcomes Retention of the diet; change in daily functioning; feasibility of the MAD in this population and setting; adverse events attributable to the MAD; predictive factors of efficacy of the diet
Starting date	8 January 2014
Contact information	H.M. Hulshof‐3@umcutrecht.nl
Notes	On 28 July 2015, the study authors reported that this trial was ongoing and was now recruiting from an additional site. They expect to end recruitment at the end of July 2016. No further update was received from the study authors for this update.