Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation Of The Efficacy Of The Modified Atkins Diet In Children With Refractory Epilepsy: A Randomized Controlled Trial.
Brief Summary: Seizures are a frequent cause of morbidity in the pediatric age group. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and/or regression, and cognitive impairment. The ketogenic diet is a well known treatment option for refractory epilepsy. However it is very restrictive and requires strict weighing of foods. The modified Atkins diet is a dietary therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. Early studies have demonstrated efficacy and safety.There are no randomized trials evaluating the efficacy of the modified Atkins diet in children with refractory epilepsy. Hence this study has been planned to investigate whether there are clear benefits in terms of seizure control in children with refractory epilepsy who are treated with the modified Atkins diet, versus controls.


Options:
A: 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
B: Inclusion Criteria:

* Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
C: 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.
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: D