The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy
The Role Of Vitamin D For Therapy Responses On Drug Resistant Epilepsy Through Glial-Cell-Line Derived Neurotrophic Factor (GDNF) And Interleukin 1ß (IL-1 ß) Modulation Pathway
1 other identifier
interventional
70
1 country
1
Brief Summary
The incident of epilepsy still very high in Indonesia, thus many patients become drug resistant epilepsy. As vitamin D has some anticonvulsant effect, the investigators want to study if an additional dose of vitamin D can help with the therapy responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedFebruary 14, 2024
February 1, 2024
12 months
August 29, 2023
February 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change of seizure frequency
Change on number of seizure
12 and 24 weeks
Secondary Outcomes (9)
Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
12 and 24 weeks
Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
12 and 24 weeks
Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
12 and 24 weeks
Responder rate
12 and 24 weeks
Remission rate after vitamin D treatment
12 and 24 weeks
- +4 more secondary outcomes
Study Arms (2)
Vitamin D
EXPERIMENTALDRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.
Placebo
PLACEBO COMPARATORDRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Age 1 - 18 years
- Drug-resistant epilepsy
- Having at least 6 unprovoked seizures in the previous 3 months
- No vitamin D treatment in the previous 6 months
- Medication compliance
- Agreeing to participate in the study
- Having a social insurance
- Parental agreement
You may not qualify if:
- Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)
- Known hypersensitivity to vitamin D
- Lost to follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, 20155, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dina K. Sari, SpGK(K), Prof.Dr.dr.
Universitas Sumatera Utara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-investigator
Study Record Dates
First Submitted
August 29, 2023
First Posted
September 25, 2023
Study Start
January 19, 2024
Primary Completion
December 31, 2024
Study Completion
July 1, 2025
Last Updated
February 14, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share