Status:
COMPLETED
Modified Atkins Diet in Childhood Epilepsy
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
Council of Scientific and Industrial Research, India
Conditions:
Refractory Childhood Epilepsy
Eligibility:
All Genders
2-14 years
Phase:
PHASE2
PHASE3
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 regres...
Detailed Description
Several severe catastrophic epilepsies present in childhood, including severe infantile myoclonic epilepsy, Lennox Gastaut syndrome and myoclonic-astatic epilepsy (Doose syndrome). Seizures in these d...
Eligibility Criteria
Inclusion
- Seizures persisting daily or more than 7 per week despite the appropriate use of at least 3 anti-epileptic drugs.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00836836
Start Date
May 1 2009
End Date
March 1 2011
Last Update
January 15 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
All India Institute of Medical sciences
New Delhi, National Capital Territory of Delhi, India, 110029