Intractable Epilepsy
Conditions
Brief summary
An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or other disorders where the KD is indicated.
Detailed description
An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or other disorders where the KD is indicated. Study is conducted over 59 days: 3 day baseline period - Patient continues on whatever dietary regimen they were on before joining the study (this may be a ketogenic diet for existing patients). 28 day control period - Patient begins ketogenic diet (if they are not already on one), and continues this for 28 days WITHOUT the study product. Patients already on a ketogenic diet continue this as normal. 28 day intervention period - A set amount of the study product is incorporated into the patient's ketogenic diet. Data is captured by the HCP in the case report form at baseline, mid study and end of intervention, and by the patient daily throughout in a patient questionnaire.
Interventions
DIETARY_SUPPLEMENTKetocal 2.5:1
A ketogenic feed for the dietary management of intractable epilepsy is given over a period of four weeks, after a control period of 4 weeks. The amount of the feed given is determined by the Dietitian and/or Doctor responsible for the patient's care (at least one carton per day).
Sponsors
Nutricia UK Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * 8 years of age or older * Diagnosed with intractable epilepsy or another disorder where the KD is indicated * Motivated to follow the KD for at least the duration of the trial period * Either currently on a KD, or referred to start a KD * Likely to benefit from Ketocal 2.5:1 * Written informed consent from patient and/or parent/carer, or completed consultee declaration form * Willing to take finger prick blood samples to measure ketone levels
Exclusion criteria
* Being pregnant or planning pregnancy * Requiring parenteral nutrition * Major hepatic or renal dysfunction * Participation in other clinical intervention studies within 1 month prior to entry of this study * Allergy to any of the study product ingredients * Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements * Any contraindications for the use of the ketogenic diet * Significantly underweight (Body Mass Index \<18.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance | Throughout study (59 days) | GI tolerance will be recorded throughout the study via standardised questionaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and Ease of Use | Measured on day 28 to represent 4 week baseline period, and also measured on day 59 (reflecting 4 week intervention period) | Acceptability and ease of use will be assessed by questionnaire completed by the parent/carer at the end of the control period (Day 28) for the KD, and at the end of the intervention period (Day 56) for both the diet as a whole and the study product alone. |
| Adverse events and Seizures | Throughout study (59 days) | All adverse events and seizures will be monitored throughout the study. |
| Nutrient intake | Throughout study (59 days) | Food diaries and 24hr recalls during baseline, control and intervention periods |
| Compliance with feed prescription | Throughout intervention period (28 days) | Compliance with the study product will be assessed daily throughout the study intervention period by recording how much feed was consumed in mls and comparing this to the amount patients have been prescribed by their Dietitian. |
| Weight | 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) | Weight (kg) |
| Ketone levels | 59 days. | Blood ketone levels captured via fingerprick blood test 9 days (3 in baseline, 3 in control period and 3 day in the intervention period), twice a day. All other ketone levels alo recorded |
| Height | 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) | Height (cm) |
Countries
United Kingdom
Outcome results
None listed