Dietary treatment of children with Angelman Syndrome and refractory epilepsy
- Conditions
- Angelman Syndrome1002929910039911
- Registration Number
- NL-OMON43592
- Lead Sponsor
- KInderneurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- Angelman syndrome (genetically proven)
- > 2 year
- < 18 year
- minimum 10 seizures per month
- Able to use > 50% of energy need by oral food.
- Written informed consent by parents
- AED use
Exclusion Criteria
- < 2 years.
- > 18 years.
- on KD or LGID treatment during the past 6 months.
- overweight: weight /height : > +2.5 SD or BMI >30
- underweight : weight/height; < - 2.5 SD.
- fully or partial (> 50% of energy need) tube feeding dependent.
- deviated lipid profiles
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- 50% seizure reduction or more after 3 months of dietary treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-observation of level of ketosis during dietary treatment. ketosis will be<br /><br>measured on daily basis by parents<br /><br>-improved EEG outcomes.<br /><br>-maintaining or improved QoL.<br /><br>-maintaining patient related growth curves.<br /><br>-safety by closely monitoring of side effects of AED and dietary treatment.<br /><br>-feasibility by monitoring behavior, feeding difficulties and parental stress<br /><br>by questionnaires .<br /><br>-protocol compliance.</p><br>