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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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16 December 2017 |
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Main ID: |
NCT03183076 |
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Date of registration:
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31/05/2017 |
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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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Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy
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Scientific title:
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Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients |
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Date of first enrolment:
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September 1, 2015 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03183076 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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María I Alanis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Mexicano del Seguro Social |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Minimum age of 18 years
- Patients that meet the criteria of drug-resistant epilepsy
- Patients treated with Rational polytherapy, a minimum of 6 months, with no changes in
their drug refractory condition.
- Patients with drug- resistant epilepsy with informed consent signed by themselves and
their proxy.
- Patients with drug-resistant epilepsy of any etiology, except tumor, metabolic,
degenerative or progressive.
Exclusion Criteria:
- Patients with drug-resistant epilepsy simultaneous alternate treatment to the Atkins
Diet modified.
- Patients with a neurological entity progressive and fatal
- Patients with congenital diseases and difficulty to metabolize fats or that require
high amounts of carbohydrates in the diet.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy, Drug Resistant
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Intervention(s)
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Drug: Pharmacotherapy without diet
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Other: modified adkins diet
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Primary Outcome(s)
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Frequency of epileptic seizures
[Time Frame: 3 months]
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Secondary Outcome(s)
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Blood chemistry (serum electrolytes)
[Time Frame: 3 months]
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Blood tests (Hematic biometry)
[Time Frame: 3 months]
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ketonuria
[Time Frame: 3 months]
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Measurement of quality of life and decrease in seizures
[Time Frame: 3 months]
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liver function tests
[Time Frame: 3 months]
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Therapeutic response observed in electroencephalogram
[Time Frame: 3 months]
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Secondary ID(s)
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F2016-1301-72
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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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