Use of the Modified Atkins Diet in Infantile Spasms (ADIS)
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ClinicalTrials.gov Identifier: NCT01006811 |
Recruitment Status :
Completed
First Posted : November 3, 2009
Last Update Posted : November 22, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infantile Spasms | Dietary Supplement: modified Atkins diet Other: modified Atkins diet | Phase 2 Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: modified Atkins diet |
Dietary Supplement: modified Atkins diet
Modified Atkins Diet administration
Other Name: Dietary treatment Other: modified Atkins diet Modified Atkins Diet administration
Other Name: Dietary treatment |
- 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
- adverse effects of the diet as per parental reports [ Time Frame: 3 months ]

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Ages Eligible for Study: | 6 Months to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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

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
India | |
All India Institute of Medical Sciences | |
New Delhi, Delhi, India, 110049 |
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 |
Responsible Party: | Dr Suvasini Sharma, All India Institute of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01006811 |
Other Study ID Numbers: |
ADIS |
First Posted: | November 3, 2009 Key Record Dates |
Last Update Posted: | November 22, 2010 |
Last Verified: | November 2010 |
West syndrome Hypsarrhythmia |
Spasm Spasms, Infantile Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases Epileptic Syndromes |