Safety and Tolerability of the Ketogenic Diet in Amyotrop... | NCT01016522

Studies
Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)

NCT01016522

Sponsor

Johns Hopkins University

Status

Terminated

Last Update Posted

Apr 1, 2015Estimated

Enrollment

1Actual

Phase

Phase 3

Conditions

Amyotrophic Lateral Sclerosis

Interventions

KetoCal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Nov 18, 2009

First Submission Date that Met QC Criteria

Nov 18, 2009

First Posted Date

Nov 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2015

Last Update Posted Date

Apr 1, 2015Estimated

Name	Class
Nutricia North America	INDUSTRY
Cornell University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Label	Type	Description	Intervention Names
KetoCal	Experimental	KetoCal tube feeding formula	Dietary Supplement: KetoCal

Name	Type	Description	Arm Group Labels	Other Names
KetoCal	Dietary Supplement	Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates	KetoCal

Measure	Description	Time Frame
Study will determine if humans with ALS fed a strictly controlled diet designed to generate large amounts of ketones is safe and well-tolerated without evidence of weight loss or other adverse effect		28 weeks

Measure	Description	Time Frame
Evaluate changes in motor function, strength, fatigue, body fat and cognitive function		28 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria
Age 18 or older
Capable of providing informed consent and complying with trial procedures
Gastrostomy tube in place for the prior month
Appel ALS score less than 100
Able to stand on a scale with assistance
For patients with Appel ALS scores greater than 80, availability of caregiver who is willing and able to:
- Prepare, administer and log tube feeds
- Check and log gastric residuals
- Assist with weighing subject at home if necessary
Willing to chart food intake during the six-month study
Patients either not taking Riluzole (Rilutek) or Minocycline or on a stable dose of these for 30 days
Not taking Coenzyme Q10 or on a stable dose and brand for 30 days
Absence of exclusion criteria

Exclusion Criteria:

Forced vital capacity <50% of predicted
Dependence on mechanical ventilation for more than 12 hours per day
Exposure to any experimental agent within 30 days of onset of this protocol
Women who are pregnant or planning to become pregnant
Women of childbearing potential not practicing contraception
Enrollment in another research study within 30 days of or during this trial
Mini-Mental State Exam (MMSE) score <20
Patients with symptomatic cardiac disease or hypercholesterolemia
Patients with myocardial infarction within 6 months of this trial
Renal dysfunction defined as BUN and creatinine >2XULN
Known mitochondrial disease
BMI<18.5
Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial
Impaired liver function, defined as AST or ALT of 3 X ULN
Patients who have a pacemaker or other internal electronic medical device

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease