NCT03196271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

May 26, 2017

Last Update Submit

July 5, 2019

Conditions

Intractable Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal tolerance

    GI tolerance will be recorded throughout the study via standardised questionaire

    Throughout study (59 days)

Secondary Outcomes (7)

  • Compliance with feed prescription

    Throughout intervention period (28 days)

  • 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)

  • Adverse events and Seizures

    Throughout study (59 days)

  • Nutrient intake

    Throughout study (59 days)

  • Height

    59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))

  • +2 more secondary outcomes

Study Arms (1)

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.

Dietary Supplement: Ketocal 2.5:1

Interventions

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 arm

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

North Bristol NHS Trust

Bristol, Bs105nb, United Kingdom

Location

University Hospitals Southampton NHS Foundation Trust

Southampton, Hampshire, S166YD, United Kingdom

Location

NHS Grampian

Aberdeen, AB156RE, United Kingdom

Location

Birmingham and Solihull Mental Health NHS Foundation Trust

Birmingham, B13RB, United Kingdom

Location

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, B46NH, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, BS13NU, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

NHS Tayside

Dundee, DD19SY, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE77DN, United Kingdom

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rebecca Stratton, PhD

    Nutricia, University of Southampton.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2017

First Posted

June 22, 2017

Study Start

January 4, 2017

Primary Completion

December 10, 2018

Study Completion

December 10, 2018

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(9)