Intractable EpilepsyNCT03196271
Ketogenic Diet Drink Study
A study testing Ketocal 2.5:1 in people with Intractable Epilepsy, run by Nutricia UK Ltd at 9 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Intractable Epilepsy
- What is being tested?
- Ketocal 2.5:1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 4 Jan 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
NHS Grampian
Aberdeen, AB156RE
Birmingham and Solihull Mental Health NHS Foundation Trust
Birmingham, B13RB
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, B46NH
North Bristol NHS Trust
Bristol, Bs105nb
University Hospitals Bristol NHS Foundation Trust
Bristol, BS13NU
Cambridge University Hospitals NHS Foundation Trust
Cambridge
NHS Tayside
Dundee, DD19SY
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE77DN
University Hospitals Southampton NHS Foundation Trust
Southampton, Hampshire, S166YD
About this study
Official title: Evaluating the Tolerance, Compliance, Acceptability and Safety of Ketocal 2.5:1 LQ, 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.
Read the 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.
- Conditions
- Intractable Epilepsy
- Being tested
- Ketocal 2.5:1
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketocal 2.5:1Dietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ketocal 2.5:1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
GI tolerance will be recorded throughout the study via standardised questionaire
Measured: Throughout study (59 days)
Secondary outcomes (7)
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.
Measured: Throughout intervention period (28 days)
Acceptability and Ease of Use
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: 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.
Measured: Throughout study (59 days)
Nutrient intake
Food diaries and 24hr recalls during baseline, control and intervention periods
Measured: Throughout study (59 days)
Height
Height (cm)
Measured: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Weight
Weight (kg)
Measured: 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
Measured: 59 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start4 Jan 2017
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Stratton, PhD, Study director, Nutricia, University of Southampton.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196271
- Sponsor's protocol ID
- K251 Study
- Status last verified
- Jul 2019
- First submitted
- 26 May 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Tolerance, Compliance, Acceptability and Safety of Ketocal 2.5:1 LQ, 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
- ClinicalTrials.gov ID
- NCT03196271
- Acronym / sponsor ID
- K251 Study
- Conditions
- Intractable Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Other | Dietary Supplement: Ketocal 2.5:1One 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketocal 2.5:1A 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). | Dietary supplement | Study arm |
Primary outcome
Gastrointestinal tolerance
Time frame: Throughout study (59 days)
GI tolerance will be recorded throughout the study via standardised questionaire
7 secondary outcomes
Compliance with feed prescription
Time frame: Throughout intervention period (28 days)
Acceptability and Ease of Use
Time frame: 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
Time frame: Throughout study (59 days)
Nutrient intake
Time frame: Throughout study (59 days)
Height
Time frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Weight
Time frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Ketone levels
Time frame: 59 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Stratton, PhD study director
Nutricia, University of Southampton.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketocal 2.5:1 in people with Intractable Epilepsy, run by Nutricia UK Ltd at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerance (time frame: Throughout study (59 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.