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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01006811 |
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Date of registration:
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01/11/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of the Modified Atkins Diet in Infantile Spasms
ADIS |
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Scientific title:
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Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study. |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01006811 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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India
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Contacts
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Name:
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Sheffali Gulati, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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All India Institute of Medical Sciences, New Delhi |
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Name:
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Suvasini Sharma, MD, DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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All India Institute of Medical Sciences, New Delhi |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
3 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infantile Spasms
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Intervention(s)
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Other: modified Atkins diet
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Dietary Supplement: modified Atkins diet
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Primary Outcome(s)
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seizure reduction as per parental reports
[Time Frame: 3 months]
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Secondary Outcome(s)
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adverse effects of the diet as per parental reports
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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