Use of the Modified Atkins Diet in Infantile Spasms

Infantile Spasms Clinical Trial

— ADIS  

Official title:

Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006811
• Other study ID #: ADIS
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 1, 2009
• Last updated: November 19, 2010
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 3 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infantile Spasms
• Spasm
• Spasms, Infantile

Intervention

Dietary Supplement:
• modified Atkins diet
Modified Atkins Diet administration Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.) Fats (e.g. cream, butter, oils, ghee) encouraged. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. Clear carbohydrate-fluids not restricted. Calcium and multivitamin supplementation will be provided.

Other:
• modified Atkins diet
Modified Atkins Diet administration Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.) Fats (e.g. cream, butter, oils, ghee) encouraged. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. Clear carbohydrate-fluids not restricted. Calcium and multivitamin supplementation will be provided.

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure reduction as per parental reports	seizure control at the end of 3 months will be classified as: spasm free; > 50% reduction in spasms; and < 50% reduction in spasms	3 months	No
Secondary	adverse effects of the diet as per parental reports		3 months	Yes