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
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Indonesia
Faculty of Medicine Universitas Sumatera Utara
RECRUITING
Medan
Contact Information
Primary
Johannes H. Saing
jhsaing@usu.ac.id
628116333784
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 70
Treatments
Experimental: Vitamin D
DRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: DINA KEUMALA SARI