The Role of Vitamin D in Neuroinflammatory on Drug Resistant Epilepsy

DINA KEUMALA SARI

Status and phase: Enrolling; Early Phase 1

Conditions: Drug Resistant Epilepsy

Treatments: Drug: Cholecalciferol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06053281

USU Neuro Pediatric

Details and patient eligibility

About

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.

Full 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)

Enrollment: 70 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

DRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). intervention: Daily Cholecalciferol 1000 IU in 24 weeks.

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Description:

DRE patients with proved vitamin D deficiency (Serum vitamin D level \<30ng/ml). Interventions: Daily Placebo oral (Manufactured to mimic Cholecalciferol) in 24 weeks.

Treatment:

Other: Placebo