Use of the Modified Atkins Diet in Infantile Spasms

NCT01006811 | Completed Phase 2 DMC

• 1 other identifier: ADIS
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Infantile Spasms

Keywords

West syndrome; Hypsarrhythmia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• adverse effects of the diet as per parental reports

  3 months

Study Arms (1)

modified Atkins diet

EXPERIMENTAL

Dietary Supplement: modified Atkins diet; Other: modified Atkins diet

Interventions

modified Atkins diet DIETARY_SUPPLEMENT

Modified Atkins Diet administration 1. 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.) 2. Fats (e.g. cream, butter, oils, ghee) encouraged. 3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. 4. Clear carbohydrate-fluids not restricted. 5. Calcium and multivitamin supplementation will be provided.

Also known as: Dietary treatment

modified Atkins diet

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.
• Motivational or psychosocial issues in the family which would preclude compliance
• Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110049, India

Location

Related Publications (1)

• 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.

  PMID: 21920781 DERIVED

MeSH Terms

Conditions

Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Suvasini Sharma, MD, DM

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Sheffali Gulati, MD

  All India Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2009
• First Posted: November 3, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 22, 2010

Record last verified: 2010-11

Locations

IN (1)