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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: |
NCT03014752 |
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Date of registration:
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31/12/2016 |
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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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Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy
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Scientific title:
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Date of first enrolment:
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September 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03014752 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Iran, Islamic Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children and adolescents age 1 to 18 years Have not responded well to at least two
primary and one secondary antiepileptic drugs Have not received ketogenic diet therapy
previously Absence of renal diseases history Absence of cardiovascular diseases
history Absence of thyroid function disorders history Absence of cholesterol level
more than 300 mg/dl and Triglyceride level more than 200 mg/dl Absence of inherited
metabolic disorders that are contraindicated for ketogenic diet therapy including
fatty acid oxidation disorders
Exclusion Criteria:
- Onset of complications that threat the life of the patient Inability to continue the
diet Unwillingness to adhere the diet
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy Intractable
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Intervention(s)
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Other: Classical ketogenic diet
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Other: Modified Atkins diet
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Primary Outcome(s)
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Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet
[Time Frame: Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet]
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Secondary Outcome(s)
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Comparison of the lipid profiles of children and adolescents on the classical KD and MAD
[Time Frame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet]
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Comparison of the nutritional status of children and adolescents on the classical KD and MAD
[Time Frame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet]
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Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD
[Time Frame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet]
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Secondary ID(s)
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9311468002
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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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