CompletedEarly Phase 1

Ketogenic Diet for Traumatic Brain Injury

United States15 participantsStarted 2019-07-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

Effect of Ketogenic Diet on Intracranial Pressure

Timeframe: Baseline, till patient on KD (maximim 1 month)

Development of Ketosis in blood

Timeframe: Baseline, till patient on KD ( maximum 1month)

Excretion of Ketones in Urine

Timeframe: Baseline, till patient on KD (maximum 1 month)

Trial details

NCT IDNCT03982602

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Traumatic Brain Injury trials