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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Other | One single arm, consisting of a 3 day baseline period, a 28 day control period and a 28 day intervention period (Ketocal 2.5:1), in that order. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketocal 2.5:1 | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance | GI tolerance will be recorded throughout the study via standardised questionaire | Throughout study (59 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with feed prescription | 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. | Throughout intervention period (28 days) |
| Acceptability and Ease of Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Stratton, PhD | Nutricia, University of Southampton. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Bristol NHS Trust | Bristol | Bs105nb | United Kingdom | |||
| University Hospitals Southampton NHS Foundation Trust |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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. |
| Measured on day 28 to represent 4 week baseline period, and also measured on day 59 (reflecting 4 week intervention period) |
| Adverse events and Seizures | All adverse events and seizures will be monitored throughout the study. | Throughout study (59 days) |
| Nutrient intake | Food diaries and 24hr recalls during baseline, control and intervention periods | Throughout study (59 days) |
| Height | Height (cm) | 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) |
| Weight | Weight (kg) | 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) |
| Ketone levels | 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 | 59 days. |
| Southampton |
| Hampshire |
| S166YD |
| United Kingdom |
| NHS Grampian | Aberdeen | AB156RE | United Kingdom |
| Birmingham and Solihull Mental Health NHS Foundation Trust | Birmingham | B13RB | United Kingdom |
| Birmingham Women's and Children's NHS Foundation Trust | Birmingham | B46NH | United Kingdom |
| University Hospitals Bristol NHS Foundation Trust | Bristol | BS13NU | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom |
| NHS Tayside | Dundee | DD19SY | United Kingdom |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE77DN | United Kingdom |