Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of the Ketogenic Diet in the Treatment of Epilepsy in Children Under the Age of Two Years
Brief Summary: Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the most common chronic neurological disorder in children. Epilepsy onset is most common in the first two years of life and is associated with poor prognosis for seizure control and neurodevelopmental outcome.

The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in children with epilepsy older than two. Associated benefits include: a reduced requirement for routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital admissions. Although reports suggest that KD therapy improves seizures in younger children there is no high quality trial data that demonstrates effectiveness and safety in this age group. The KD is resource intensive, requiring dietetic and physician time; data is required to justify expansion of services to cater for the apparent need.

The investigators therefore propose a prospective multicentre randomised trial to investigate the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have failed to respond to two or more AEDs. Children will be randomly assigned to either receive the KD or further AEDs. The allocated treatment will be started after a 2week baseline period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record seizures and related events, a questionnaire will be used to assess diet tolerance; also growth and blood biochemistry will be monitored.

The information obtained from this study is necessary to optimise choices in epilepsy treatment, aiming to improve outcomes and thus determine whether and when the KD should should be used.


Options:
A: Inclusion Criteria:

* Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
B: Inclusion Criteria:

* Age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.

Exclusion Criteria

* Patients heve been tried KD or MAD before.
* Patients with renal stones, hyperlipidemia, cardiologic problems.
* Other conditions not adjust for dietary therapy.
C: Inclusion Criteria:

1. Age between 1 month and 24 months of age (not beyond second birthday at baseline).
2. Diagnosis of epilepsy confirmed.
3. At least an average of 4 seizures/week in baseline period.
4. Failed response to previous trial of two anti-epileptic drugs. In the case of infantile spasms this could include a trial of corticosteroids.
5. Children with written informed consent from parent/guardian.

Exclusion Criteria:

1. Age \<1m or \> 24 months of age
2. No secure diagnosis of epilepsy
3. \< 4 seizures/week on average in baseline period
4. Trial of \< 2 AEDs
5. Continues on corticosteroids in previous 3 months prior to randomisation
6. Metabolic disease contraindicating use of the ketogenic diet e.g. pyruvate carboxylase deficiency, MCAD from previous medical investigation and screening at baseline.
7. Progressive neurological disease
8. Severe gastroesophageal reflux
9. Previous treatment with the ketogenic diet
10. Concurrent participation in another clinical trial of an investigational medicinal product.
11. Patients who are prescribed AEDs not listed in the trial IMPs
D: Inclusion Criteria:

* Seizures persisting daily or more than 7 per week despite the appropriate use of at least 3 anti-epileptic drugs.

Exclusion Criteria:

* Known or suspected inborn error of metabolism
* Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following:

  * a history of parental consanguinity
  * prior affected siblings
  * unexplained vomiting
  * intermittent worsening of symptoms
  * recurrent episodes of lethargy
  * altered sensorium, or ataxia
  * hepatosplenomegaly on examination
* And/ or 2 or more of the following biochemical abnormalities

  * High blood ammonia (\>80mmol/L)
  * High arterial lactate (\>2 mmol/L)
  * metabolic acidosis (pH \<7.2)
  * hypoglycaemia (blood sugar \<40 mg/dl)
  * abnormal urinary aminoacidogram
  * presence of reducing sugars or ketones in urine
  * positive results on urine neurometabolic screening tests
* Motivational or psychosocial issues in the family which would preclude compliance
* Systemic illness- chronic hepatic, renal or pulmonary disease

Answer: C