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

This study has been terminated.

Sponsor:

Collaborators:

Nutricia North America

Cornell University

Information provided by (Responsible Party):

Vinay Chaudhry, Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01016522

First received: November 18, 2009

Last updated: November 17, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 18, 2009
Last Updated Date	November 17, 2011
Start Date ^ICMJE	November 2009
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 18, 2009)	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 [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01016522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 18, 2009)	Evaluate changes in motor function, strength, fatigue, body fat and cognitive function [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)
Official Title ^ICMJE	Safety and Tolerability of the Ketogenic Diet in ALS
Brief Summary	This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Amyotrophic Lateral Sclerosis
Intervention ^ICMJE	Dietary Supplement: KetoCal Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates Other Name: KetoCal
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	1
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01016522
Other Study ID Numbers ^ICMJE	NA_00008855
Has Data Monitoring Committee	Yes
Responsible Party	Vinay Chaudhry, Johns Hopkins University
Study Sponsor ^ICMJE	Johns Hopkins University
Collaborators ^ICMJE	Nutricia North America Cornell University
Investigators ^ICMJE	Not Provided
Information Provided By	Johns Hopkins University
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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