The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy
NCT ID: NCT06053281
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
70 participants
INTERVENTIONAL
2024-01-19
2025-07-01
Brief Summary
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Detailed Description
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1. Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
2. Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
3. Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
4. Responder rate. Percentage of patients change of at least 50% of the seizure frequency
5. Remission rate after vitamin D treatment. Percentage of patients without any seizure (seizure freedom)
6. Effect of vitamin D according to epilepsy type. Responder rate in focal and generalized epilepsy.
7. Effect on Global Assesment of the Severity of Epilepsy (GASE)
8. Effect on Hague Seizure Severity scale (HASS)
9. Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vitamin D
DRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.
Cholecalciferol
Daily Cholecalciferol 1000 IU in 24 weeks
Placebo
DRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks.
Placebo
Placebo
Interventions
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Cholecalciferol
Daily Cholecalciferol 1000 IU in 24 weeks
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Drug-resistant epilepsy
3. Having at least 6 unprovoked seizures in the previous 3 months
4. No vitamin D treatment in the previous 6 months
5. Medication compliance
6. Agreeing to participate in the study
7. Having a social insurance
8. Parental agreement
Exclusion Criteria
2. Known hypersensitivity to vitamin D
3. Lost to follow up
1 Year
18 Years
ALL
No
Sponsors
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DINA KEUMALA SARI
OTHER
Responsible Party
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DINA KEUMALA SARI
Sponsor-investigator
Principal Investigators
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Dina K. Sari, SpGK(K), Prof.Dr.dr.
Role: PRINCIPAL_INVESTIGATOR
Universitas Sumatera Utara
Locations
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Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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USU Neuro Pediatric
Identifier Type: -
Identifier Source: org_study_id
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