NCT01016522
Terminated
Phase 3
Safety and Tolerability of the Ketogenic Diet in ALS
ConditionsAmyotrophic Lateral Sclerosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- Johns Hopkins University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Investigators
Vinay Chaudhry
Professor
Johns Hopkins University
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
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Evaluate changes in motor function, strength, fatigue, body fat and cognitive function(28 weeks)
Study Sites (1)
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