ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01006811
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : November 22, 2010
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Infantile Spasms Dietary Supplement: modified Atkins diet Other: modified Atkins diet Phase 2 Phase 3

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. seizure reduction as per parental reports [ Time Frame: 3 months ]
    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 :
  1. adverse effects of the diet as per parental reports [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: November 22, 2010
Last Verified: November 2010

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

Additional relevant MeSH terms:
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases