A pilot study on the use of Ketocal Infant in administering the ketogenic diet
- Conditions
- childhood epilepsyrefractory epilepsy10039911
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
Infant aged 0-24
clinical indication for use of the ketogenic diet for either treatment of epilepsy or disorder of carbohydrate metabolism responsive to the ketogenic diet
will take the majority of prescribed calorie intake from Ketocal Infant (70-100%)
Informed consent obtained
infant over 24 months
presence of other acute ilness like vomiting, sepsis
diabetes mellitus
metabolic disorders such a fatty acid disorders
carnitine deficiency
Pyruvate carboxylase deficiency
ketotic hypoglycemia
clinical suspicion of mitochondrial enzym deficiency
less than 70% of intake of prescribed calorie requirements from Ketocal Infant
milkintolerance
Unable to adhere to protocol instructions
investigators uncertainty about willingness of ability of the subject to comply with the protocol requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>intake and tolerance will be assassed by<br /><br>- comparising of the amount of Ketocal Infant consumed versus prescribed intake<br /><br>- documentation of tolerance to Ketocal Infant by the prescriber with due<br /><br>considerations given to intake and effect on GI symptoms (constipation,<br /><br>diarrhoea, vomiting )</p><br>
- Secondary Outcome Measures
Name Time Method <p>Seizure and ketosis effect by<br /><br>- bloodketones to determine the effect of Ketocal Infant on ketosis<br /><br>- Seizure type and frequency recorded to determine effect on seizure reduction<br /><br>- Effect on symptoms ( level of sedation, muscle tone ) and reduction in<br /><br>medication will be recorded<br /><br><br /><br>Growth will be measurede and recorded by<br /><br>- weight<br /><br>- length<br /><br>- head circumference</p><br>