Ketogenic Diet for Traumatic Brain Injury

Completed · Early Phase 1

Conditions studied: Traumatic Brain Injury, Ketogenic Dieting

In brief

Traumatic Brain Injury is a major health concern in United States. There is a un-met need to develop new therapeutic options for faster neuron recovery without causing significant side effects. The role of ketones in neuronal recovery has been studied and has been found to be useful in decreasing size of contusion. The present study aims to study the safety and feasibility profile of ketogenic diet.

Key facts

Study ID

NCT03982602

Run by

University of Missouri-Columbia

People needed

15

Starts

2019-07-04

Expected to finish

2024-04-30

Last updated by the study team

2024-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe Traumatic Brain Injury
• GCS<= 8 with severe head injury
• Age more than 18years

You may not qualify if…

• Diabetic Ketoacidosis
• Unstable metabolic condition (persistent hyponatremia, hypernatremia, hypoglycemia, hypocalcemia, acidosis)
• Cardiorespiratory or hemodynamic instability
• Coagulopathy
• Pancreatitis
• Liver Failure
• Severe hyperlipidemia
• Inability to tolerate enteral feeds including ileus
• Known Fatty acid oxidation disorder or pyruvate carboxylase deficiency
• Any terminally ill patient with poor brain stem reflexes and mortality within 24h of admission.
• Pregnant Females

Where it is running

• University of Missouri Hospital — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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