Clinical trial NCT01006811: Use of the Modified Atkins Diet in Infantile Spasms
Official title: Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infantile Spasms
Keywords: West syndrome
Hypsarrhythmia
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children. The modified Atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. Modified Atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. Hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).


Eligibility criteria: Inclusion Criteria:

1. Age: 6 months to 3 years.
2. Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day.
3. Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam).

Exclusion Criteria:

1. Known or suspected inborn error of metabolism, as evidenced by: 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, and positive results on urine neurometabolic screening tests.
2. Motivational or psychosocial issues in the family which would preclude compliance
3. Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease

Primary outcomes:
measure: seizure reduction as per parental reports
timeFrame: 3 months
Secondary outcomes:
measure: adverse effects of the diet as per parental reports
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Suvasini Sharma, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Sheffali Gulati, MD
role: STUDY_DIRECTOR
References:
citation: Sharma S, Sankhyan N, Gulati S, Agarwala A. Use of the modified Atkins diet in infantile spasms refractory to first-line treatment. Seizure. 2012 Jan;21(1):45-8. doi: 10.1016/j.seizure.2011.08.009. Epub 2011 Sep 14.