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The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

Recruiting
1-18 years
All
Phase N/A

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Overview

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.

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

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

Study details
    Drug Resistant Epilepsy

NCT06053281

DINA KEUMALA SARI

20 February 2024

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