Clinical trial NCT06053281: The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Drug Resistant Epilepsy
Keywords: vitamin D
GDNF
interleukin
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind
Primary purpose: TREATMENT

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.

Detailed description: Specifically the investigators want to study about :

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)

Eligibility criteria: Inclusion Criteria:

1. Age 1 - 18 years
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:

1. Treatments influencing the metabolism of vitamin D other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)
2. Known hypersensitivity to vitamin D
3. Lost to follow up

Primary outcomes:
measure: Percentage change of seizure frequency
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: Correlation between serum vitamin D levels and seizure frequency change after vitamin D treatment
timeFrame: 12 and 24 weeks
measure: Correlation between serum GDNF levels and seizure frequency change after vitamin D treatment
timeFrame: 12 and 24 weeks
measure: Correlation between serum Interleukin-1ß levels and seizure frequency change after vitamin D treatment
timeFrame: 12 and 24 weeks
measure: Responder rate
timeFrame: 12 and 24 weeks
measure: Remission rate after vitamin D treatment
timeFrame: 12 and 24 weeks
measure: Effect of vitamin D according to epilepsy type
timeFrame: 12 and 24 weeks
measure: Effect on Global Assessment of the Severity of Epilepsy (GASE)
timeFrame: 12 and 24 weeks
measure: Effect on Hague Seizure Severity scale (HASS)
timeFrame: 12 and 24 weeks
measure: Effect on Quality of Life in Epilepsy in Children: (QOLCE 55)
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: Faculty of Medicine Universitas Sumatera Utara
state: North Sumatra
Study officials:
affiliation: Universitas Sumatera Utara
name: Dina K. Sari, SpGK(K), Prof.Dr.dr.
role: PRINCIPAL_INVESTIGATOR
References: