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Use of the Modified Atkins Diet in Infantile Spasms (ADIS)

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01006811
First received: November 1, 2009
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Infantile Spasms
 Dietary Supplement: modified Atkins diet
Other: modified Atkins diet
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • seizure reduction as per parental reports [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    seizure control at the end of 3 months will be classified as: spasm free; > 50% reduction in spasms; and < 50% reduction in spasms


Secondary Outcome Measures:
  • adverse effects of the diet as per parental reports [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 15
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: modified Atkins diet Dietary Supplement: modified Atkins diet

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.
Other Name: Dietary treatment
Other: modified Atkins diet

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.
Other Name: Dietary treatment

  Eligibility
Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006811

Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110049
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Suvasini Sharma, MD, DM All India Institute of Medical Sciences, New Delhi
Study Director: Sheffali Gulati, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Suvasini Sharma, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT01006811     History of Changes
Other Study ID Numbers: ADIS
Study First Received: November 1, 2009
Last Updated: November 19, 2010
Health Authority: India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:
West syndrome
Hypsarrhythmia

Additional relevant MeSH terms:
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
 Epilepsy
Epilepsy, Generalized
Nervous System Diseases

ClinicalTrials.gov processed this record on February 27, 2015